An interventional study of ABSORB GT1 BVS in Ischemic Heart Disease, Angina Pectoris and Coronary Artery Disease, sponsored by Abbott Medical Devices. Completed at 15 sites in Japan. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Abbott Medical Devices (part of Abbott) · Not applicable, Interventional, and Prevention
Among 44 studies in Myocardial Ischemia by Abbott Medical Devices — none open to participants now, 2 under way, none of them phase 3. Myocardial Ischemia · Abbott Medical Devices.
Among the 44 studies in Myocardial Ischemia by Abbott Medical Devices, this one is the 21st largest by enrollment of the 30 interventional ones, is the only one that started in 2016, is one of 17 with no phase, and was the 43rd registered.
1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.
This study's enrollment of 135 is above the median of 116 across 622 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →None of the 44 studies in Myocardial Ischemia by Abbott Medical Devices is open now.
Of the 135 Myocardial Ischemia studies recruiting now, 92 (68%) set no upper age limit and 6 (4%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →44 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 1 started in 2016.
Median enrollment 428 across the 30 interventional studies, 1,000 across the 14 observational. Of the 41 that completed or were terminated, 26 (63%) have results posted.
Abbott Medical Devices is the lead sponsor of 539 studies on the registry; 33 are open to participants now.
Of its 53 completed or terminated interventional studies of FDA-regulated products, 44 (83%) have results posted.
1 of the studies in Myocardial Ischemia by Abbott Medical Devices that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07373353Abbott Medical DevicesA Clinical Evaluation of AMJ-401 | 2027-01-31 |
Among the 44 studies in Myocardial Ischemia by Abbott Medical Devices, from their registry updates:
The purpose of the Surveillance is to know the frequency and status of adverse device effects and adverse events in order to assure the safety of the new medical device, and to collect efficacy and safety information for evaluating clinical use results.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients receiving Absorb GT1 Bioresorbable Vascular Scaffold System.
Device: ABSORB GT1 BVS
Patients receiving Absorb GT1 BVS
Number of Participants With Acute Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Time frame: Day 0
Number of Participants With Sub Acute Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Time frame: >1 to 30 days
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Time frame: 31 to 90 days
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Time frame: 31 to 365 days
Number of Participants With Very Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Time frame: 366 to 730 days
Number of Participants With Overall Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 0 to 90 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 0 to 90 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 0 to 730 days
Number of Participants With Exclusion of Very Small Vessels
For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD \< 2.5 mm from registration by the last half of Phase 1.
Time frame: During index procedure, "54.8 ± 27.6 min"
Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging
IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
Time frame: During index procedure, "54.8 ± 27.6 min"
Number of Participants With Composite of Device Deficiencies
Device deficiencies: Number of participants with at least one of the following Device deficiencies 1. Lesion/implant failure 2. Delivery difficulty (finally delivered) 3. Re-crossing failure 4. Re-crossing difficulty 5. Post-dilatation balloon 6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) 7. Instruction for Use (IFU) not included 8. Major Strut Malapposition 9. Strut Fracture within 6 months
Time frame: During index procedure, "54.8 ± 27.6 min"
Number of Participants With Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Time frame: 731 - 1095 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 0 - 1095 days
Number of Participants With Very Late Scaffold Thrombosis (ST)
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 1096 - 1460 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
Time frame: 0 - 1460 days
Number of Participants With Cumulative Scaffold Thrombosis
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
Time frame: 0 - 1825 days
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 30 days
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 90 days
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 1 year
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 0 to 2 years
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time frame: 0 to 30 days
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time frame: 0 to 90 days
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time frame: 0 to 1 year
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time frame: 0 to 2 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 0 to 30 days
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 0 to 90 days
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 0 to 1 year
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 0 to 2 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 0 to 30 days
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 0 to 90 days
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 0 to 1 year
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 0 to 2 years
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time frame: 0 to 30 days
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time frame: 0 to 90 days
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time frame: 0 to 1 year
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time frame: 0 to 2 years
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 30 days
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 90 days
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 1 year
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 0 to 2 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 30 days
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 0 to 90 days
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Time frame: 0 to 1 Year
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
Time frame: 0 to 2 years
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time frame: 0 to 30 days
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time frame: 0 to 90 days
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time frame: 0 to 1 year
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time frame: 0 to 2 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 30 days
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 90 days
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 1 year
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 0 to 2 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 0 to 30 days
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 0 to 90 days
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 0 to 1 year
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 0 to 2 years
Angiographic Endpoints (Core Lab Analysis): Lesion Morphology
Time frame: Pre-procedure
Angiographic Endpoints (Core Lab Analysis):Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Time frame: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Lesion Length
Lesion Length (can be measured after successful post-dilatation)
Time frame: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD)
Proximal RVD (can be measured after successful post-dilatation)
Time frame: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Distal RVD
Distal RVD (can be measured after successful post-dilatation)
Time frame: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD)
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen
Time frame: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time frame: Pre-procedure
Angiographic Endpoints (Core Lab Analysis): Thrombolysis in Myocardial Infarction (TIMI) Blood Flow
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
Time frame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
Angiographic Endpoints (Core Lab Analysis): MLD (In-segment)
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Time frame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment )
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Time frame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment )
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Time frame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
Time frame: Pre-procedure (or after pre-dilatation)
IVUS/OCT Endpoints (Core Lab Analysis): Lumen Diameter or Lumen Area (Proximal/Distal)
Time frame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area
Time frame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition
Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure
Time frame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Strut Fracture
Strut fracture will be measured as either number or percentage post-procedure
Time frame: Post-procedure (average procedure time of "54.8 ± 27.6 min")
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 3 years
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time frame: 3 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 3 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 3 years
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time frame: 3 years
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 3 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 3 years
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time frame: 3 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 3 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 3 years
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 4 years
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time frame: 4 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 4 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 4 years
Number of Participants With All Coronary Revascularization
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
Time frame: 4 years
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
Time frame: 4 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 4 years
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
Time frame: 4 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 4 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 4 years
Number of All Death (Cardiac, Vascular, Non-Cardiovascular)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time frame: 5 years
Number of Participants With All Myocardial Infarction (MI)
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
Time frame: 5 years
Number of Participants With All Target Lesion Revascularization (TLR)
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
Time frame: 5 years
Number of Participants With All Target Vessel Revascularization (TVR)
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time frame: 5 years
Number of Death/MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time frame: 5 years
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time frame: 5 years
Number of Major Adverse Cardiac Event (MACE)
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR).
Time frame: 5 years
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 5 years
Number of Participants With Cardiac Death/Myocardial Infarction (MI)
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
Time frame: 5 years
This surveillance planned to consecutively enroll two thousand (2,000) patients. However, in September 2017, Abbott Vascular decided to stop selling the Absorb GT1 system globally, as result of low commercial sales uptake compared to the prediction. Surveillance sites could continue to use the device and register patients until December 15, 2017. As a result, 135 patients were enrolled (treatment with Absorb GT1 attempted, i.e., ITT) by December 11, 2017.
| Milestone | Absorb GT1 BVS |
|---|---|
| Started | 135 |
| Completed | 114 |
| Not completed | 21 |
| Withdrew: Withdrawal by subject | 17 |
| Withdrew: Death | 4 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
| participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.
| participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.
| participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation.
| participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
| Participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
| Participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
| participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation Very late scaffold/stent thrombosis: \>1 year post stent implantation
| Participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
For Phase 1 patients, Angiograms and IVUS/OCT images taken during procedure will be sent immediately to the core lab. Additional training or revision of registration criteria may occur as required in order to exclude almost all lesions with RVD \< 2.5 mm from registration by the last half of Phase 1.
| participants | Absorb GT1 BVS |
|---|---|
| < 2.25 mm | 18 |
| ≥ 2.25 mm - < 2.5 mm | 26 |
| ≥ 2.5 mm - ≤ 3.5 mm | 91 |
| > 3.5 mm | 4 |
IVUS/OCT images taken during procedure will be sent immediately to the core lab, which will analyze the images and give feedback to the site as required. Images of ST, if occurred, will also be sent to the core lab.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Scaffold Apposition Assessed by Intravascular Imaging | 5 |
Device deficiencies: Number of participants with at least one of the following Device deficiencies 1. Lesion/implant failure 2. Delivery difficulty (finally delivered) 3. Re-crossing failure 4. Re-crossing difficulty 5. Post-dilatation balloon 6. Optical Coherence Tomography (OCT)/Intravascular Ultrasound (IVUS) 7. Instruction for Use (IFU) not included 8. Major Strut Malapposition 9. Strut Fracture within 6 months
| Participants | Absorb GT1 BVS |
|---|---|
| Lesion/implant failure | 0 |
| Delivery difficulty (finally delivered) | 6 |
| Re-crossing failure | 1 |
| Re-crossing difficulty | 0 |
| Post-dilatation balloon+OCT/IVUS | 11 |
| IFU not included | 1 |
| Major Strut Malapposition | 1 |
| Strut Fracture within 6 months | 1 |
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
| Participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
| Participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
| Participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients : sum of Phase 1 and Phase 2),Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis : 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation
| Participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Criteria: ST rate (in 2,000 patients: sum of Phase 1 and Phase2), Success Criteria: ST rate at 3 months is ≤ 18 patients (0.9%). Scaffold/Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the subject left the catheterization lab. Timings: Acute scaffold/stent thrombosis: 0 - 24 hours post stent implantation; Subacute scaffold/stent thrombosis: \>24 hours - 30 days post stent implantation; Late scaffold/stent thrombosis: 30 days - 1 year post stent implantation; Very late scaffold/stent thrombosis: \>1 year post stent implantation.
| participants | Absorb GT1 BVS |
|---|---|
| Definite | 0 |
| Probable | 0 |
| Definite/Probable | 0 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | 0 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | 2 |
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Myocardial Infarction (MI) | 0 |
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Myocardial Infarction (MI) | 0 |
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Myocardial Infarction (MI) | 0 |
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Myocardial Infarction (MI) | 0 |
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Lesion Revascularization (TLR) | 1 |
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Lesion Revascularization (TLR) | 1 |
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Lesion Revascularization (TLR) | 1 |
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Lesion Revascularization (TLR) | 3 |
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Vessel Revascularization (TVR) | 1 |
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Vessel Revascularization (TVR) | 1 |
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Vessel Revascularization (TVR) | 1 |
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Vessel Revascularization (TVR) | 4 |
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Coronary Revascularization | 1 |
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Coronary Revascularization | 1 |
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Coronary Revascularization | 3 |
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Coronary Revascularization | 9 |
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Death/MI/All Revascularization (DMR) | 1 |
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Death/MI/All Revascularization (DMR) | 1 |
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Death/MI/All Revascularization (DMR) | 3 |
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Death/MI/All Revascularization (DMR) | 11 |
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Target Vessel Failure (TVF) | 0 |
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Target Vessel Failure (TVF) | 0 |
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Target Vessel Failure (TVF) | 0 |
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Target Vessel Failure (TVF) | 4 |
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Major Adverse Cardiac Event (MACE) | 0 |
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Major Adverse Cardiac Event (MACE) | 0 |
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Major Adverse Cardiac Event (MACE) | 0 |
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Major Adverse Cardiac Event (MACE) | 3 |
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 0 |
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 0 |
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 0 |
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 3 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | 0 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | 0 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | 0 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | 1 |
| percentage of lesions | Absorb GT1 BVS |
|---|---|
| ACC/AHA Type B2/C | 51.8 |
| Severe/Moderate Calcification | 11.5 |
| Eccentric | 27.3 |
| Total Occlusion | 0.0 |
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
| percentage of TIMI flow | Absorb GT1 BVS |
|---|---|
| 0 | 0.00 |
| 1 | 0.72 |
| 2 | 2.16 |
| 3 | 97.12 |
Lesion Length (can be measured after successful post-dilatation)
| mm | Absorb GT1 BVS |
|---|---|
| Angiographic Endpoints (Core Lab Analysis): Lesion Length | 13.84 ± 4.74 |
Proximal RVD (can be measured after successful post-dilatation)
| mm | Absorb GT1 BVS |
|---|---|
| Angiographic Endpoints (Core Lab Analysis): Proximal Reference Vessel Diameter (RVD) | 3.15 ± 0.49 |
Distal RVD (can be measured after successful post-dilatation)
| mm | Absorb GT1 BVS |
|---|---|
| Angiographic Endpoints (Core Lab Analysis): Distal RVD | 2.95 ± 0.39 |
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen
| mm | Absorb GT1 BVS |
|---|---|
| Angiographic Endpoints (Core Lab Analysis): Minimum Lumen Diameter (MLD) | 1.00 ± 0.30 |
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
| percentage of diameter | Absorb GT1 BVS |
|---|---|
| Angiographic Endpoints (Core Lab Analysis): Percent Diameter Stenosis (%DS) | 63.1 ± 9.5 |
TIMI 0 flow (no perfusion) refers to the absence of any antegrade flow beyond a coronary occlusion. TIMI 1 flow (penetration without perfusion) is faint antegrade coronary flow beyond the occlusion, with incomplete filling of the distal coronary bed. TIMI 2 flow (partial reperfusion) is delayed or sluggish antegrade flow with complete filling of the distal territory. TIMI 3 is normal flow which fills the distal coronary bed completely
| percentage of TIMI flow | Absorb GT1 BVS |
|---|---|
| 0 | 0.00 |
| 1 | 0.72 |
| 2 | 1.44 |
| 3 | 97.84 |
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
| mm | Absorb GT1 BVS |
|---|---|
| Angiographic Endpoints (Core Lab Analysis): MLD (In-segment) | 2.30 ± 0.38 |
Percent Diameter Stenosis is defined as the value calculated as 100 \* (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
| percentage of diameter | Absorb GT1 BVS |
|---|---|
| Angiographic Endpoints (Core Lab Analysis): %DS (In-Segment ) | 18.4 ± 6.3 |
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
| mm | Absorb GT1 BVS |
|---|---|
| Angiographic Endpoints (Core Lab Analysis): Acute Gain (In-Segment ) | 1.29 ± 0.44 |
| mm^2 | Absorb GT1 BVS |
|---|---|
| Proximal | 8.04 ± 2.51 |
| Distal | 6.29 ± 2.30 |
| mm^2 | Absorb GT1 BVS |
|---|---|
| Proximal | 8.21 ± 2.47 |
| Distal | 6.54 ± 2.21 |
| mm^2 | Absorb GT1 BVS |
|---|---|
| IVUS/OCT Endpoints (Core Lab Analysis): Minimal Lumen Area | 6.86 ± 1.77 |
Percentage of lesions with strut malapposition will be calculated as mean ± standard deviation post-procedure
| Percentage of lesions | Absorb GT1 BVS |
|---|---|
| IVUS/OCT Endpoints (Core Lab Analysis): Percentage of Lesions With Strut Malapposition | 1.89 ± 3.63 |
Strut fracture will be measured as either number or percentage post-procedure
| Lesions | Absorb GT1 BVS |
|---|---|
| Yes | 1 |
| No | 138 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | 3 |
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Myocardial Infarction (MI) | 2 |
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Lesion Revascularization (TLR) | 4 |
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Vessel Revascularization (TVR) | 7 |
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Coronary Revascularization | 12 |
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Death/MI/All Revascularization (DMR) | 16 |
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Target Vessel Failure (TVF) | 8 |
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Major Adverse Cardiac Event (MACE) | 6 |
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 5 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | 3 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | 4 |
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Myocardial Infarction (MI) | 2 |
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Lesion Revascularization (TLR) | 6 |
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Vessel Revascularization (TVR) | 11 |
All coronary revascularization is a composite of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Coronary Revascularization | 16 |
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Death/MI/All Revascularization (DMR) | 22 |
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Target Vessel Failure (TVF) | 11 |
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Major Adverse Cardiac Event (MACE) | 7 |
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 6 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | 4 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of All Death (Cardiac, Vascular, Non-Cardiovascular) | 4 |
Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI)
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Myocardial Infarction (MI) | 2 |
Target Lesion Revascularization is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as clinically indicated \[CI\] or not clinically indicated by the investigator prior to repeat angiography. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the scaffold/stent.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Lesion Revascularization (TLR) | 6 |
Target Vessel Revascularization (TVR) is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With All Target Vessel Revascularization (TVR) | 11 |
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Death/MI/All Revascularization (DMR) | 23 |
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Target Vessel Failure (TVF) | 11 |
MACE is the composite of Cardiac death/All myocardial infarction (MI)/ Ischemia-driven Revascularization (ID-TLR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Major Adverse Cardiac Event (MACE) | 7 |
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Cardiac Death/TV-MI/ID-TLR (TLF) | 6 |
Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment.
| Participants | Absorb GT1 BVS |
|---|---|
| Number of Participants With Cardiac Death/Myocardial Infarction (MI) | 4 |
Collected over 5 Years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Absorb GT1 BVS | 4/135 (3%) | 43/135 (31.9%) | 8/135 (5.9%) |
| Event | Absorb GT1 BVS |
|---|---|
| Angina pectorisCardiac disorders | 14/135 |
| Coronary artery diseaseCardiac disorders | 13/135 |
| HaemorrhageVascular disorders | 5/135 |
| Colonic polypGastrointestinal disorders | 3/135 |
| Angina, unstableCardiac disorders | 2/135 |
| Myocardial infarctionCardiac disorders | 2/135 |
| CataractEye disorders | 2/135 |
| Colitis ischaemicGastrointestinal disorders | 2/135 |
| CholecystitisHepatobiliary disorders | 2/135 |
| PneumoniaInfections and infestations | 2/135 |
| Event | Absorb GT1 BVS |
|---|---|
| HaemorrhageVascular disorders | 6/135 |
| Coronary artery diseaseCardiac disorders | 1/135 |
| Thrombosis in DeviceGeneral disorders | 1/135 |
| Cerebral artery stenosisNervous system disorders | 1/135 |
| Dermal EruptionSkin and subcutaneous tissue disorders | 1/135 |
| Coronary RevascularizationSurgical and medical procedures | 1/135 |
| Age, Continuous(years) | Absorb GT1 BVS |
|---|---|
| Mean | 64.0 ± 10.9 |
| Sex: Female, Male(Participants) | Absorb GT1 BVS |
|---|---|
| Female | 21 |
| Male | 114 |
| Ethnicity (NIH/OMB)(Participants) | Absorb GT1 BVS |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 135 |
| Race (NIH/OMB)(Participants) | Absorb GT1 BVS |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 135 |
| Region of Enrollment(participants) | Absorb GT1 BVS |
|---|---|
| Japan | 135 |
| Diabetes Mellitus(Participants) | Absorb GT1 BVS |
|---|---|
| Count of participants | 53 |
| Dyslipidemia(Participants) | Absorb GT1 BVS |
|---|---|
| Count of participants | 84 |
| Hypertension(Participants) | Absorb GT1 BVS |
|---|---|
| Count of participants | 93 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Dec 2016 to primary completion in Feb 2023, 73 months.
Of 37 industry-sponsored interventional studies with no phase under Myocardial Ischemia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's 73 months is above that.
Counting every sponsor, half of 192 studies reached it within 34 months; a quarter within 15 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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