CClinicalTrials.gg
Sign In
CompletedNCT02229864Updated Mar 12, 2021Results posted

Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions

An interventional study of Coronary artery stenting: Absorb BVS in Coronary Artery Disease, Coronary Artery Stenosis and Coronary Disease, sponsored by Abbott Medical Devices. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-03-12.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The ABSORB III PK sub-study is a prospective, open-label, non-blinded study enrolling approximately 12 subjects in up to 5 US sites. ABSORB III PK sub-study is a part of ABSORB III RCT (NCT01751906). The objective is to determine the pharmacokinetics of everolimus delivered by the Absorb BVS in a separate and non-randomized cohort of subjects who only receive Absorb BVS with a maximum of two de novo native coronary artery lesions after implantation of the Absorb BVS.

Note: The ABSORB III PK subjects will not contribute to the determination of the ABSORB III RCT primary endpoint.

Read the detailed description

To ensure the PK measurements reflect everolimus exposure due to Absorb BVS only, the PK sub-study will not allow non-target lesion treatment.

Blood Sampling Timing:

  • Pre-Absorb BVS implantation: Baseline

    o Baseline is defined as prior to implantation of the first Absorb BVS; the blood sample will be drawn on the day of the index procedure either through a heparin lock, venous sheath, or venipuncture.

  • Post-Absorb BVS implantation: 10 and 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 24 hrs (1 day), 48 hrs (2 days), 72 hrs (3 days), 96 hrs (4 days), 120 hrs (5 days), 168 hrs (7 days), 336 hrs (14 days), and 720 hrs (30 days).

    • Post-implantation blood samples will be drawn at the time intervals stated above; timing of the post-implantation sampling will begin when the last Absorb BVS is deployed, i.e. last Absorb BVS delivery catheter is removed from the body.

Pharmacokinetic (PK) parameters will include time to maximum concentration (tmax); maximum concentration (Cmax); AUC24h: Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS; AUClast: Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration; AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time; terminal elimination rate constant (λz); terminal elimination half-life (t1/2term); drug clearance (CL).

02

Conditions studied

  • Coronary Artery Disease
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Stenosis

Keywords

  • Absorb™ BVS
  • Angioplasty
  • Bioabsorbable
  • BVS
  • Coronary Artery Disease
  • Coronary Artery Endothelial Responsiveness
  • Coronary artery restenosis
  • Coronary artery stenosis
  • Coronary scaffold
  • Coronary Stent
  • Drug eluting stents
  • Everolimus
  • Myocardial ischemia
  • Stent thrombosis
  • Stents
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 12 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

General Inclusion Criteria:

  1. 18 years of age.
  2. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements.
  3. Evidence of myocardial. In the absence of noninvasive ischemia, FFR must be done and indicative of ischemia.
  4. An acceptable candidate for coronary artery bypass graft (CABG) surgery.
  5. Female subject of childbearing potential who does not plan pregnancy for up to 1 year following the index procedure.
  6. Female subject is not breast-feeding at the time of the screening visit and will not be breast-feeding for up to 1 year following the index procedure.
  7. Subject agrees to not participate in any other investigational or invasive clinical study for a period of 1 year following the index procedure.

Angiographic Inclusion Criteria:

  1. One or two de novo target lesions:

    1. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
    2. The definition of epicardial vessels means the left anterior descending (LAD), left coronary artery (LCX), and right coronary artery (RCA) and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.

  2. Target lesion(s) must be located in a native coronary artery with a visually estimated or quantitatively assessed % diameter stenosis (DS) of ≥ 50% and \< 100% with a thrombolysis in myocardial infarction (TIMI) flow of ≥ 1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g., fractional flow reserve (FFR), stress test), unstable angina or post-infarct angina.

    1. Lesion(s) must be located in a native coronary artery with reference vessel diameter (RVD) by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm.
    2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.

General Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an Adenosine diphosphate receptor (ADP) antagonist is planned within 12 months after the procedure.
  2. Subject has known hypersensitivity or contraindication to device material and its degradants (everolimus, poly (L-lactide), poly (DL-lactide), lactide, lactic acid) and cobalt, chromium, nickel, platinum, tungsten, acrylic and fluoro polymers that cannot be adequately pre-medicated. Subject has a known contrast sensitivity that cannot be adequately pre-medicated.
  3. Subject has known allergic reaction, hypersensitivity or contraindication to aspirin; or to clopidogrel and prasugrel and ticagrelor; or to heparin and bivalirudin, and therefore cannot be adequately treated with study medications.
  4. Subject had an acute myocardial infarction (AMI: STEMI or NSTEMI) within 72 hours of the index procedure and both creatine kinase (CK) and creatine kinase myocardial-band isoenzyme (CK-MB) have not returned to within normal limits at the time of index procedure; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure.
  5. Subject is currently experiencing clinical symptoms consistent with new onset AMI (STEMI or NSTEMI), such as nitrate-unresponsive prolonged chest pain with ischemic ECG changes.

  6. Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met:

    1. Subject requires coumadin or any other agent for chronic oral anticoagulation
    2. Subject is likely to become hemodynamically unstable due to their arrhythmia
    3. Subject has poor survival prognosis due to their arrhythmia
  7. Subject has a left ventricular ejection fraction (LVEF) \< 30%
  8. Subject has undergone prior percutaneous coronary intervention (PCI) within the target vessel(s) during the last 12 months.
  9. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions \< 30 days after the index procedure.
  10. Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants.
  11. At the time of screening, the subject has a malignancy that is not in remission.
  12. Subject is receiving immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  13. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum.
  14. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason).
  15. Subject has a platelet count \< 100,000 cells/mm3 or > 700,000 cells/mm3.
  16. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  17. Subject has renal insufficiency as defined as an estimated glomerular filtration rate (GFR) \< 30 ml/min/1.73m2 or dialysis at the time of screening.
  18. Subject is high risk of bleeding for any reason; has a history of bleeding diathesis or coagulopathy; has had a significant gastro-intestinal or significant urinary bleed within the past six months.
  19. Subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc.).
  20. Subject has extensive peripheral vascular disease that precludes safe 6 French sheath insertion. Note: femoral arterial disease does not exclude the patient if radial access may be used.
  21. Subject has life expectancy \< 5 years for any non-cardiac cause or cardiac cause.
  22. Subject is in the opinion of the Investigator or designee, unable to comply with the requirements of the study protocol or is unsuitable for the study for any reason.
  23. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint.
  24. Subject is part of a vulnerable population

Angiographic Exclusion Criteria:

All exclusion criteria apply to the target lesion(s) or target vessel(s).

  1. Lesion which prevents successful balloon pre-dilatation
  2. Lesion is located in left main.
  3. Aorto-ostial RCA lesion.
  4. Lesion located within 3 mm of the origin of the LAD or LCX.

  5. Lesion involving a bifurcation with a:

    1. side branch ≥ 2 mm in diameter, or
    2. side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or
    3. side branch requiring dilatation.
  6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS.
  7. Vessel contains thrombus as indicated in the angiographic images or by intravascular ultrasound (IVUS) or optical coherence tomography (OCT).
  8. Lesion or vessel involves a myocardial bridge.
  9. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Absorb BVS would need to cross the stent to reach the target lesion.
  10. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
  11. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Coronary artery stenting: Absorb BVS

    Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)

    Device: Coronary artery stenting: Absorb BVS

Interventions

  • DeviceCoronary artery stenting: Absorb BVS

    * Scaffold diameters: 2.5, 3.0 and 3.5 mm * Scaffold lengths: 8, 12, 18, and 28 mm

06

What researchers measure

Primary outcomes

  1. Maximum Concentration (Cmax)

    Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

    Time frame: 0 to 30 days

  2. Time of Maximum (Tmax)

    Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

    Time frame: 0 to 30 days

  3. AUC24h

    Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.

    Time frame: 0 to 24 hours

  4. AUC Last

    Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.

    Time frame: 0 to 30 days

  5. AUC 0-infinity

    AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ \* 100

    Time frame: 0 to 30 days

  6. Terminal Elimination Rate Constant (λz)

    The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.

    Time frame: 0 to 30 days

  7. Terminal Elimination Half-life (t1/2term)

    The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: t1/2term = 0.693/λz.

    Time frame: 0 to 30 days

  8. Drug Clearance (CL)

    The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated as: CL = Dose/AUC0 - ∞ .

    Time frame: 0 to 30 days

Secondary outcomes

  1. Number of Participants With Target Lesion Failure (TLF)

    Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).

    Time frame: 0 to 1853 Days

  2. Number of Participants With All Death

    All death includes cardiac death, vascular death, and non-cardiac death.

    Time frame: 0 to 1853 Days

  3. Number of Participants With All Myocardial Infarction (MI)

    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).

    Time frame: 0 to 1853 Days

  4. Number of Participants With All Target Lesion Revascularization (TLR)

    All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).

    Time frame: 0 to 1853 Days

  5. Number of Participants With All Target Vessel Revascularization (TVR)

    All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).

    Time frame: 0 to 1853 Days

  6. Number of Participants With All Revascularization

    All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.

    Time frame: 0 to 1853 Days

  7. Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)

    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 day

  8. Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)

    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

  9. Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)

    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 393 days

  10. Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)

    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 1853 Days

07

Results

Posted Dec 14, 2016

Participant flow

The first subject was enrolled on June 2, 2014 and the last subject was enrolled on September 17, 2014. The last 30-day follow-up visit occurred on October 14, 2014. Database was locked on Oct 29, 2014.

Participant flow — Overall Study
MilestoneCoronary Artery Stenting: Absorb BVS
Started12
Completed9
Not completed3
Withdrew: Death2
Withdrew: Lost to follow-up1

Outcome measures

PrimaryMaximum Concentration (Cmax)

Maximal observed blood analyte concentration. Cmax is the highest blood everolimus concentration reached during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

Time frame:
0 to 30 days
Reported as:
Median · nanograms per milliliter
Maximum Concentration (Cmax)
nanograms per milliliterCoronary Artery Stenting: Absorb BVS
Maximum Concentration (Cmax)2.397 (1.085 to 4.460)
PrimaryTime of Maximum (Tmax)

Time to reach the maximal observed blood analyte concentration during the 30 day period of the study after assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation).

Time frame:
0 to 30 days
Reported as:
Median · Hours
Time of Maximum (Tmax)
HoursCoronary Artery Stenting: Absorb BVS
Time of Maximum (Tmax)0.55 (0.17 to 2.37)
PrimaryAUC24h

Area under the blood analyte concentration vs. time curve from time 0 up to 24 hours post placement of the last Absorb BVS. Calculated by the Lin Up Log Down trapezoidal method.

Time frame:
0 to 24 hours
Reported as:
Median · ng*h/mL
AUC24h
ng*h/mLCoronary Artery Stenting: Absorb BVS
AUC24h22.67 (12.09 to 44.22)
PrimaryAUC Last

Area under the blood analyte concentration vs. time curve from time 0 up to the last quantifiable concentration reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated by the Lin Up Log Down trapezoidal method.

Time frame:
0 to 30 days
Reported as:
Median · ng*h/mL
AUC Last
ng*h/mLCoronary Artery Stenting: Absorb BVS
AUC Last55.90 (25.37 to 104.6)
PrimaryAUC 0-infinity

AUC 0-infinity: Area under the blood analyte concentration vs. time curve from time zero and extrapolated to infinite time, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: AUC0-∞ = AUClast + (Clast/λz) The percentage of AUC0-∞ obtained by extrapolation (%AUC0-∞ex) is calculated as: %AUC0-∞ex = (AUC0-∞ - AUClast)/ AUC0-∞ \* 100

Time frame:
0 to 30 days
Reported as:
Median · ng*h/mL
AUC 0-infinity
ng*h/mLCoronary Artery Stenting: Absorb BVS
AUC 0-infinity72.02 (33.15 to 120.8)
PrimaryTerminal Elimination Rate Constant (λz)

The apparent terminal elimination rate constant during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Determined by linear regression of terminal points of the ln-linear analyte concentration-time curve.

Time frame:
0 to 30 days
Reported as:
Median · 1/hour
Terminal Elimination Rate Constant (λz)
1/hourCoronary Artery Stenting: Absorb BVS
Terminal Elimination Rate Constant (λz)0.01092 (0.006027 to 0.01511)
PrimaryTerminal Elimination Half-life (t1/2term)

The apparent terminal elimination half-life, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). calculated as: t1/2term = 0.693/λz.

Time frame:
0 to 30 days
Reported as:
Median · Hours
Terminal Elimination Half-life (t1/2term)
HoursCoronary Artery Stenting: Absorb BVS
Terminal Elimination Half-life (t1/2term)63.5 (45.9 to 115.0)
PrimaryDrug Clearance (CL)

The systemic drug clearance, reached during the 30 day period of the study. After assessing at different time frames (10 minutes, 30 minutes, 1 hr, 2 hrs, 4 hrs, 6 hrs , 12 hrs, 1 day, 2 days, 3 days, 4 days, 5 days, 7 days, 14 days, and 30 days post implantation). Calculated as: CL = Dose/AUC0 - ∞ .

Time frame:
0 to 30 days
Reported as:
Median · Liter/hour
Drug Clearance (CL)
Liter/hourCoronary Artery Stenting: Absorb BVS
Drug Clearance (CL)3.451 (2.421 to 5.460)
SecondaryNumber of Participants With Target Lesion Failure (TLF)

Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).

Time frame:
0 to 1853 Days
Reported as:
Count of participants · Participants
Number of Participants With Target Lesion Failure (TLF)
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With Target Lesion Failure (TLF)2
SecondaryNumber of Participants With All Death

All death includes cardiac death, vascular death, and non-cardiac death.

Time frame:
0 to 1853 Days
Reported as:
Count of participants · Participants
Number of Participants With All Death
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With All Death2
SecondaryNumber of Participants With All Myocardial Infarction (MI)

All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).

Time frame:
0 to 1853 Days
Reported as:
Count of participants · Participants
Number of Participants With All Myocardial Infarction (MI)
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With All Myocardial Infarction (MI)4
SecondaryNumber of Participants With All Target Lesion Revascularization (TLR)

All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).

Time frame:
0 to 1853 Days
Reported as:
Count of participants · Participants
Number of Participants With All Target Lesion Revascularization (TLR)
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With All Target Lesion Revascularization (TLR)0
SecondaryNumber of Participants With All Target Vessel Revascularization (TVR)

All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).

Time frame:
0 to 1853 Days
Reported as:
Count of participants · Participants
Number of Participants With All Target Vessel Revascularization (TVR)
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With All Target Vessel Revascularization (TVR)1
SecondaryNumber of Participants With All Revascularization

All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.

Time frame:
0 to 1853 Days
Reported as:
Count of participants · Participants
Number of Participants With All Revascularization
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With All Revascularization3
SecondaryNumber of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)

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 day
Reported as:
Count of participants · Participants
Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With Acute Stent/Scaffold Thrombosis (Definite/Probable)0
SecondaryNumber of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)

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
Reported as:
Count of participants · Participants
Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With Subacute Stent/Scaffold Thrombosis (Definite/Probable)0
SecondaryNumber of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)

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 393 days
Reported as:
Count of participants · Participants
Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With Late Stent/Scaffold Thrombosis (Definite/Probable)0
SecondaryNumber of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)

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 1853 Days
Reported as:
Count of participants · Participants
Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)
ParticipantsCoronary Artery Stenting: Absorb BVS
Number of Participants With Cumulative Stent/Scaffold Thrombosis (Definite/Probable)0

Adverse events

Collected over 5 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Coronary Artery Stenting: Absorb BVS2/12 (16.7%)10/12 (83.3%)12/12 (100%)
Most frequent serious events
Showing 10 of 27
Most frequent serious events
EventCoronary Artery Stenting: Absorb BVS
LUMBAR SPINAL STENOSISMusculoskeletal and connective tissue disorders3/12
ANGINA PECTORISCardiac disorders1/12
ANGINA PECTORIS AGGRAVATEDCardiac disorders1/12
ARRHYTHMIACardiac disorders1/12
ATRIAL FIBRILLATION AGGRAVATEDCardiac disorders1/12
ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSECardiac disorders1/12
NON STEMICardiac disorders1/12
STABLE ANGINA PECTORISCardiac disorders1/12
UNSTABLE ANGINACardiac disorders1/12
SMALL BOWEL OBSTRUCTIONGastrointestinal disorders1/12
Most frequent other events
Showing 10 of 56
Most frequent other events
EventCoronary Artery Stenting: Absorb BVS
CHEST PAIN (NON-CARDIAC)General disorders4/12
ANGINA PECTORISCardiac disorders3/12
CORONARY ARTERY DISSECTIONCardiac disorders3/12
CREATINE KINASE MB INCREASEDInvestigations3/12
LUMBAR SPINAL STENOSISMusculoskeletal and connective tissue disorders3/12
CHEST PAIN - CARDIACCardiac disorders2/12
BRONCHITISInfections and infestations2/12
CARDIAC ENZYMES INCREASEDInvestigations2/12
ANGINA PECTORIS AGGRAVATEDCardiac disorders1/12
ARRHYTHMIACardiac disorders1/12

Baseline characteristics

The PK sub-study had slightly more male subjects, and slightly more subjects with dyslipidemia and hypertension requiring medication and subjects with stable angina as compared to ABSORB III Primary Analysis Group. The PK sub-study had fewer subjects who had undergone prior coronary intervention.

Age, Continuous
Age, Continuous(years)Coronary Artery Stenting: Absorb BVS
Mean60.1 ± 10.5
Sex: Female, Male
Sex: Female, Male(Participants)Coronary Artery Stenting: Absorb BVS
Female1
Male11
Region of Enrollment
Region of Enrollment(Participants)Coronary Artery Stenting: Absorb BVS
United States12
Hypertension Requiring Medication
Hypertension Requiring Medication(Participants)Coronary Artery Stenting: Absorb BVS
Count of participants12
Dyslipidemia Requiring Medication
Dyslipidemia Requiring Medication(Participants)Coronary Artery Stenting: Absorb BVS
Count of participants12
Prior Coronary Intervention
Prior Coronary Intervention(Participants)Coronary Artery Stenting: Absorb BVS
Count of participants1
Stable Angina
Stable Angina(Participants)Coronary Artery Stenting: Absorb BVS
Count of participants9
08

Study locations

2 sites
  • Scottsdale Healthcare
    Scottsdale, Arizona 85258, United States
  • Cardiac & Vascular Research Center of Northern Michigan
    Petoskey, Michigan 49770, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 16, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02229864
Lead sponsor
Abbott Medical Devices
Responsible party
Sponsor
First posted
Sep 3, 2014
Start date
May 2014
Primary completion
Oct 2014
Completion
Oct 1, 2019
Results posted
Dec 14, 2016
Last update
Mar 12, 2021

Study contacts

David G. Rizik, MD
principal investigator · Scottsdale Healthcare, Scottsdale, AZ
Louis A. Cannon, MD
principal investigator · Cardiac and Vascular Research Center of Northern Michigan Petoskey, MI

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Coronary Artery Disease→

Other studies from this sponsor

Abbott Medical Devices

Start the discussion