An interventional study of Stellarex 0.035" OTW Drug-coated Angioplasty Balloon and EverCross™ 0.035 PTA Balloon Catheter in Peripheral Artery Disease, sponsored by Spectranetics Corporation. Completed at 41 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-02.
Sponsored by Spectranetics Corporation (part of Philips) · Not applicable, Interventional, and Treatment
The ILLUMENATE Pivotal PAS is a continued follow-up study which will include 300 subjects from forty-three (43) sites across the United States and Austria previously enrolled in the ILLUMENATE Pivotal pre-market study to evaluate the Stellarex DCB compared to the PTA control device for the treatment of de-novo or post-PTA occluded/stenotic or reoccluded/restenotic (except for in-stent) SFA and/or popliteal arteries.
The objective of this continued follow-up of ILLUMENATE Pivotal Study subjects is to demonstrate the long term safety and effectiveness of the Stellarex DCB.
Each enrolled subject will be followed for 5 years (60 months) after treatment. A follow-up office visit will occur at 24 and 36 months. A follow-up telephone contact or an optional office visit will occur at 48 and 60 months.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 300 is above the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Spectranetics Corporation is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
First submitted after Spectranetics Corporation became part of Philips.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria - From ILLUMENATE Pivotal IDE population TP-1397E
Study subjects must fulfill the following clinical criteria:
Rutherford-Becker classification of 2, 3 or 4.
Study Subjects must fulfill the following angiographic criteria:
Exclusion Criteria -
Subject with any of the following clinical criteria should be excluded:
Chronic renal insufficiency (dialysis dependent, or serum creatinine >2.5 mg/dL within 30 days of index procedure).
Subject with any of the following angiographic criteria should be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Stellarex DCB is a commercially available PTA balloon catheter (EverCross™ 0.035" PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier. Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater than or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm The nominal dose density of paclitaxel on the Stellarex DCB is 2.0 μg/mm2. Indications The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
Device: Stellarex 0.035" OTW Drug-coated Angioplasty Balloon
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA). Basic Catheter Specifications * Guidewire: 0.035" * Balloon Length: 40/80/120 mm * Sheath Compatibility: greater to or equal to 6 French * Balloon Diameter: 4/5/6 mm * Shaft length: 135 cm Indications The EverCross Balloon Catheter is intended to dilate stenosis in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and to treat obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilation in the peripheral vasculature. For additional information refer to the EverCross Instructions for Use.
Device: EverCross™ 0.035 PTA Balloon Catheter
The Stellarex 0.035" OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
Number of Participants With Target Vessel Patency at 24 Months Post-procedure
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Time frame: 24 months post-procedure
Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure
The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).
Time frame: 24 months post-procedure
Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 24 months post-procedure
Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 36 months post-procedure
Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 48 months post-procedure
Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR)
Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
Time frame: 60 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 24 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 36 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 48 months post-procedure
Rate of Clinically-driven Target Lesion Revascularization
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
Time frame: 60 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 24 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 36 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 48 months post-procedure
Rate of Target Lesion Revascularization
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
Time frame: 60 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 24 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 36 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 48 months post-procedure
Rate of Clinically-driven Target Vessel Revascularization
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
Time frame: 60 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 24 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 36 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 48 months post-procedure
Rate of Target Limb Major Amputation
Number of subjects in which a major amputation occurred in the target limb
Time frame: 60 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 24 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 36 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 48 months post-procedure
Mortality Rate
Number of subject who have died during the post-procedure follow up period
Time frame: 60 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 24 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 36 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 48 months post-procedure
Rate of Occurrence of Arterial Thrombosis of the Treated Segment
Rate of occurrence of arterial thrombosis of the treated segment
Time frame: 60 months post-procedure
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR
Time frame: 24 months post-procedure
Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR
Time frame: 36 months post-procedure
Change in Ankle-brachial Index (ABI) From Pre-procedure
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Time frame: 24 months post-procedure
Change in Ankle-brachial Index (ABI) From Pre-procedure
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
Time frame: 36 months post-procedure
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
Time frame: 24 months post-procedure
Change in Walking Impairment Questionnaire (WIQ) From Pre-procedure
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
Time frame: 36 months post-procedure
Change in Walking Distance From Pre-procedure
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.
Time frame: 24 months post-procedure
Change in Walking Distance From Pre-procedure
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.
Time frame: 36 months post-procedure
Change in Rutherford-Becker Classification From Pre-procedure
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.
Time frame: 24 months post-procedure
Change in Rutherford-Becker Classification From Pre-procedure
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.
Time frame: 36 months post-procedure
Change in EQ-5D Index From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
Time frame: 24 months post-procedure
Change in EQ-5D Index From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
Time frame: 36 months post-procedure
Change in EQ-5D VAS From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
Time frame: 24 months post procedure
Change in EQ-5D VAS From Pre-procedure
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
Time frame: 36 month post procedure
| Milestone | DCB Subjects | PTA Subjects |
|---|---|---|
| Started | 200 | 100 |
| Completed | 135 | 70 |
| Not completed | 65 | 30 |
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Number of Participants With Target Vessel Patency at 24 Months Post-procedure | 88 | 45 |
The primary safety outcome is defined as freedom from device and procedure-related death through 30 days post-procedure and freedom from target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) through 24 months post-procedure (defined as 730 ± 45 days, i.e., up to 775 days).
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Number of Participants With Freedom From Device and Procedure Related Death Through 30 Days Post-procedure and Freedom From Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization Through 24 Months Post-procedure | 142 | 73 |
Major adverse event (MAE) rate at 24 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Major Adverse Event (MAE) Rate at 24 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 34 | 22 |
Major adverse event (MAE) rate at 36 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Major Adverse Event (MAE) Rate at 36 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 46 | 27 |
Major adverse event (MAE) rate at 48 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Major Adverse Event (MAE) Rate at 48 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 55 | 33 |
Major adverse event (MAE) rate at 60 months post-procedure, defined as a composite rate of cardiovascular death, target limb major amputation and clinically-driven target lesion revascularization (TLR).
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Major Adverse Event (MAE) Rate at 60 Months Post-procedure, Defined as a Composite Rate of Cardiovascular Death, Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization (TLR) | 64 | 37 |
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Clinically-driven Target Lesion Revascularization | 29 | 19 |
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Clinically-driven Target Lesion Revascularization | 38 | 24 |
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Clinically-driven Target Lesion Revascularization | 44 | 28 |
Lesion revascularization occurring in the target lesion deemed clinically driven by the Clinical Events Committee. Clinically-driven target lesion revascularization is a repeat revascularization procedure at the target lesion due to a peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or a percent diameter stenosis \>50% by angiography accompanied by worsening of the Rutherford Becker Clinical Category or Ankle Brachial Index that is clearly referable to the target lesion.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Clinically-driven Target Lesion Revascularization | 51 | 29 |
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Target Lesion Revascularization | 32 | 20 |
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Target Lesion Revascularization | 42 | 25 |
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Target Lesion Revascularization | 48 | 29 |
Lesion revascularization occuring in the target lesion deemed clinically driven by the Clinical Events Committee
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Target Lesion Revascularization | 55 | 30 |
Lesion revascularization occuring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Clinically-driven Target Vessel Revascularization | 1 | 1 |
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Clinically-driven Target Vessel Revascularization | 3 | 1 |
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Clinically-driven Target Vessel Revascularization | 3 | 2 |
Lesion revascularization occurring in the target vessel deemed clinically driven by the Clinical Events Committee. A clinically-driven target vessel revascularization is a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. A revascularization of the target vessel is considered clinically-driven if the peak systolic velocity ratio ≥ 2.5 by duplex ultrasound or if angiography shows a percent diameter stenosis \>50% and there is worsening of the Rutherford Becker Clinical Category or Ankle-Brachial Index.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Clinically-driven Target Vessel Revascularization | 3 | 2 |
Number of subjects in which a major amputation occurred in the target limb
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Target Limb Major Amputation | 1 | 0 |
Number of subjects in which a major amputation occurred in the target limb
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Target Limb Major Amputation | 1 | 0 |
Number of subjects in which a major amputation occurred in the target limb
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Target Limb Major Amputation | 2 | 0 |
Number of subjects in which a major amputation occurred in the target limb
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Target Limb Major Amputation | 2 | 0 |
Number of subject who have died during the post-procedure follow up period
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Mortality Rate | 13 | 8 |
Number of subject who have died during the post-procedure follow up period
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Mortality Rate | 18 | 10 |
Number of subject who have died during the post-procedure follow up period
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Mortality Rate | 27 | 14 |
Number of subject who have died during the post-procedure follow up period
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Mortality Rate | 34 | 19 |
Rate of occurrence of arterial thrombosis of the treated segment
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 3 | 0 |
Rate of occurrence of arterial thrombosis of the treated segment
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 4 | 0 |
Rate of occurrence of arterial thrombosis of the treated segment
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 4 | 0 |
Rate of occurrence of arterial thrombosis of the treated segment
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Rate of Occurrence of Arterial Thrombosis of the Treated Segment | 4 | 0 |
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | 88 | 45 |
Patency rate defined as the absence of target lesion restenosis as determined by duplex ultrasound (PSVR ≤ 2.5) and freedom from clinically-driven TLR
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Patency Rate Defined as the Absence of Target Lesion Restenosis as Determined by Duplex Ultrasound (PSVR ≤ 2.5) and Freedom From Clinically-driven TLR | 65 | 35 |
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 102 | 56 |
| No Change | 0 | 1 |
| Worsened | 39 | 22 |
The ankle-brachial index (ABI) is the ratio of the blood pressure at the ankle to the blood pressure in the upper arm (brachium). The normal range for the ankle-brachial index is between 0.90 and 1.30. An index under 0.90 means that blood is having a hard time getting to the legs and feet: 0.41 to 0.90 indicates mild to moderate peripheral artery disease; 0.40 and lower indicates severe disease.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 89 | 46 |
| Worsened | 31 | 23 |
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 114 | 63 |
| Worsened | 39 | 19 |
A disease-specific instrument utilized to characterize walking ability through a questionnaire. It is a measure of patient-perceived walking performance for patients with PAD and/or intermittent claudication
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 98 | 50 |
| No Change | 1 | 0 |
| Worsened | 32 | 24 |
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 24 month office visit.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 92 | 57 |
| No Change | 1 | 1 |
| Worsened | 49 | 22 |
Distance in meters or feet traveled in 6 minutes measured at pre-procedure and at 36 month office visit.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 77 | 47 |
| No Change | 2 | 0 |
| Worsened | 35 | 22 |
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 128 | 74 |
| No Change | 17 | 5 |
| Worsened | 8 | 3 |
Rutherford-Becker Classification is a classification system of Peripheral Arterial Disease, the higher the number the worse the disease. Category Clinical Description 0-Asymptomatic--no hemodynamically significant occlusive disease Mild claudication Moderate claudication Severe claudication 4\*-Ischemic rest pain 5\*-Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia 6\*-Major tissue loss-extending above transmetatarsal level, functional foot no longer salvageable \*Categories 4, 5, and 6 are also described as critical limb ischemia.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 108 | 63 |
| No Change | 15 | 11 |
| Worsened | 7 | 2 |
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 62 | 37 |
| No Change | 9 | 7 |
| Worsened | 32 | 15 |
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion.
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 52 | 35 |
| No Change | 15 | 6 |
| Worsened | 28 | 15 |
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 52 | 30 |
| No Change | 12 | 10 |
| Worsened | 40 | 19 |
EQ-5D is designed for self-completion by subjects and is intended to reflect the health status at the time of completion
| Participants | DCB Subjects | PTA Subjects |
|---|---|---|
| Improved | 53 | 26 |
| No Change | 6 | 9 |
| Worsened | 36 | 21 |
Collected over Adverse Event reporting begins at the time the subject is enrolled in the study and continues through their exit which can be as long as 60 months. Please note these patients are a roll-over from NCT01858428 and continues the subjects follow-up.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DCB Subjects | 34/200 (17%) | 177/200 (88.5%) | 192/200 (96%) |
| PTA Subjects | 19/100 (19%) | 85/100 (85%) | 95/100 (95%) |
| Event | DCB Subjects | PTA Subjects |
|---|---|---|
| PERIPHERAL ARTERY STENOSISVascular disorders | 45/200 | 27/100 |
| INTERMITTENT CLAUDICATIONVascular disorders | 43/200 | 18/100 |
| PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications | 24/200 | 13/100 |
| Chest PainGeneral disorders | 20/200 | 8/100 |
| PneumoniaInfections and infestations | 14/200 | 9/100 |
| FEMORAL ARTERY DISSECTIONVascular disorders | 17/200 | 6/100 |
| RENAL FAILURE ACUTERenal and urinary disorders | 14/200 | 3/100 |
| Atrial FibrillationCardiac disorders | 8/200 | 6/100 |
| Cardiac Failure CongestiveCardiac disorders | 12/200 | 5/100 |
| Coronary Artery DiseaseCardiac disorders | 12/200 | 4/100 |
| Event | DCB Subjects | PTA Subjects |
|---|---|---|
| INTERMITTENT CLAUDICATIONVascular disorders | 74/200 | 35/100 |
| PERIPHERAL ARTERY STENOSISVascular disorders | 54/200 | 34/100 |
| PAIN IN EXTREMITYMusculoskeletal and connective tissue disorders | 48/200 | 21/100 |
| PERIPHERAL ARTERY RESTENOSISInjury, poisoning and procedural complications | 30/200 | 18/100 |
| CHEST PAINGeneral disorders | 35/200 | 17/100 |
| ARTHRALGIAMusculoskeletal and connective tissue disorders | 20/200 | 15/100 |
| DYSPNOEARespiratory, thoracic and mediastinal disorders | 29/200 | 11/100 |
| Atrial FibrillationCardiac disorders | 12/200 | 11/100 |
| OEDEMA PERIPHERALGeneral disorders | 13/200 | 11/100 |
| LOCAL SWELLINGGeneral disorders | 7/200 | 10/100 |
| Age, Continuous(years) | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| Mean | 68.3 ± 10.3 | 69.8 ± 9.8 | 68.8 ± 10.2 |
| Sex: Female, Male(Participants) | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| Female | 88 | 36 | 124 |
| Male | 112 | 64 | 176 |
| Ethnicity (NIH/OMB)(Participants) | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| Hispanic or Latino | 27 | 11 | 38 |
| Not Hispanic or Latino | 152 | 77 | 229 |
| Unknown or Not Reported | 21 | 12 | 33 |
| Race (NIH/OMB)(Participants) | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 0 | 2 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | NA | NA | NA |
| Black or African American | 35 | 19 | 54 |
| White | 142 | 68 | 210 |
| More than one race | NA | NA | NA |
| Unknown or Not Reported | 19 | 12 | 31 |
| Region of Enrollment(participants) | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| Austria | 17 | 10 | 27 |
| United States | 183 | 90 | 273 |
| Body Mass Index(kg/m^2) | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| Mean | 29.0 ± 6.1 | 28.8 ± 5.6 | 29.0 ± 6.0 |
| Ankle-Brachial Index(ratio) | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| Ankle-Brachial Index Measurement | 0.75 ± 0.21 | 0.76 ± 0.20 | 0.75 ± 0.21 |
| Non-Compressible | NA ± NA | — | NA ± NA |
| Rutherford-Becker Clinical Category(Participants) | DCB Subjects | PTA Subjects | Total |
|---|---|---|---|
| RCC 2 | 63 | 35 | 98 |
| RCC 3 | 129 | 60 | 189 |
| RCC 4 | 8 | 5 | 13 |
18 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2013 to primary completion in Dec 2017, 53 months.
Results were first posted in Feb 2024, 6 years 1 month after primary completion.
Of 125 industry-sponsored interventional studies with no phase under Peripheral Arterial Disease, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 45. This study's 53 months is above that.
Counting every sponsor, half of 385 studies reached it within 31 months; a quarter within 17 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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