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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229864
Recruitment Status : Completed
First Posted : September 3, 2014
Results First Posted : December 14, 2016
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Tracking Information
First Submitted Date  ICMJE June 9, 2014
First Posted Date  ICMJE September 3, 2014
Results First Submitted Date  ICMJE May 23, 2016
Results First Posted Date  ICMJE December 14, 2016
Last Update Posted Date November 22, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2017)
  • Maximum Concentration (Cmax) [ Time Frame: 0 to 30 days ]
    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 of Maximum (Tmax) [ Time Frame: 0 to 30 days ]
    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).
  • AUC24h [ Time Frame: 0 to 24 hours ]
    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.
  • AUC Last [ Time Frame: 0 to 30 days ]
    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.
  • AUC 0-infinity [ Time Frame: 0 to 30 days ]
    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
  • Terminal Elimination Rate Constant (λz) [ Time Frame: 0 to 30 days ]
    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.
  • Terminal Elimination Half-life (t1/2term) [ Time Frame: 0 to 30 days ]
    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.
  • Drug Clearance (CL) [ Time Frame: 0 to 30 days ]
    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 - ∞ .
Original Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
To assess the PK parameters of tmax, Cmax, AUC0-24hours, AUC0-t, AUC0-∞, λz, t1/2term, CL within a 30-day period. [ Time Frame: up to 30 days post-procedure ]
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.
Change History Complete list of historical versions of study NCT02229864 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 7, 2018)
  • Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
  • Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR) [ Time Frame: 0 to 37 days ]
    Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
  • Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR) [ Time Frame: 0 to 208 Days ]
    Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
  • Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR) [ Time Frame: 0 to 393 Days ]
    Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
  • Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR) [ Time Frame: 0 to 758 Days ]
    Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
  • Number of Subjects With Target Lesion Failure (Cardiac Death, TVMI, TLR) [ Time Frame: 0 to 1123 Days ]
    Target Lesion Failure (TLF) includes Cardiac Death, Target vessel - myocardial infarction and Target Lesion Revascularization (TLR).
  • Number of Subjects With All Death [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    All death includes cardiac death, vascular death, and non-cardiac death.
  • Number of Subjects With All Death [ Time Frame: 0 to 37 Days ]
    All death includes cardiac death, vascular death, and non-cardiac death.
  • Number of Subjects With All Death [ Time Frame: 0 to 208 Days ]
    All death includes cardiac death, vascular death, and non-cardiac death.
  • Number of Subjects With All Death [ Time Frame: 0 to 393 Days ]
    All death includes cardiac death, vascular death, and non-cardiac death.
  • Number of Subjects With All Death [ Time Frame: 0 to 758 Days ]
    All death includes cardiac death, vascular death, and non-cardiac death.
  • Number of Subjects With All Death [ Time Frame: 0 to 1123 Days ]
    All death includes cardiac death, vascular death, and non-cardiac death.
  • Number of Subjects With All Myocardial Infarction (MI) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
  • Number of Subjects With All Myocardial Infarction (MI) [ Time Frame: 0 to 37 Days ]
    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
  • Number of Subjects With All Myocardial Infarction (MI) [ Time Frame: 0 to 208 Days ]
    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
  • Number of Subjects With All Myocardial Infarction (MI) [ Time Frame: 0 to 393 Days ]
    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
  • Number of Subjects With All Myocardial Infarction (MI) [ Time Frame: 0 to 758 Days ]
    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
  • Number of Subjects With All Myocardial Infarction (MI) [ Time Frame: 0 to 1123 Days ]
    All myocardial infarction includes target vessel myocardial infarction (TV-MI) and not attributable to target vessel myocardial infarction (NTV-MI).
  • Number of Subjects With All Target Lesion Revascularization (TLR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
  • Number of Subjects With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 37 Days ]
    All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
  • Number of Subjects With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 208 Days ]
    All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
  • Number of Subjects With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 393 Days ]
    All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
  • Number of Subjects With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 758 Days ]
    All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
  • Number of Subjects With All Target Lesion Revascularization (TLR) [ Time Frame: 0 to 1123 Days ]
    All target lesion revascularization includes ischemia-driven target lesion revascularization (ID-TLR) and non ischemia-driven target lesion revascularization (NID-TLR).
  • Number of Subjects With All Target Vessel Revascularization (TVR) [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
  • Number of Subjects With All Target Vessel Revascularization (TVR) [ Time Frame: 0 to 37 Days ]
    All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
  • Number of Subjects With All Target Vessel Revascularization (TVR) [ Time Frame: 0 to 208 Days ]
    All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
  • Number of Subjects With All Target Vessel Revascularization (TVR) [ Time Frame: 0 to 393 Days ]
    All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
  • Number of Subjects With All Target Vessel Revascularization (TVR) [ Time Frame: 0 to 758 Days ]
    All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
  • Number of Subjects With All Target Vessel Revascularization (TVR) [ Time Frame: 0 to 1123 Days ]
    All target vessel revascularization includes ischemia driven target vessel revascularization (ID-TVR) and non ischemia driven target vessel revascularization (NID-TVR).
  • Number of Subjects With All Revascularization [ Time Frame: ≤ 7 days post index procedure (In-hospital ) ]
    All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
  • Number of Subjects With All Revascularization [ Time Frame: 0 to 37 Days ]
    All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
  • Number of Subjects With All Revascularization [ Time Frame: 0 to 208 Days ]
    All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
  • Number of Subjects With All Revascularization [ Time Frame: 0 to 393 Days ]
    All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
  • Number of Subjects With All Revascularization [ Time Frame: 0 to 758 Days ]
    All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
  • Number of Subjects With All Revascularization [ Time Frame: 0 to 1123 Days ]
    All revascularization includes ischemia driven revascularization and non ischemia driven revascularization.
  • Number of Subjects With Acute Stent/Scaffold Thrombosis (Definite/Probable) [ Time Frame: ≤ 1 day ]
    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
  • Number of Subjects With Subacute Stent/Scaffold Thrombosis (Definite/Probable) [ Time Frame: >1 to 30 days ]
    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
  • Number of Subjects With Late Stent/Scaffold Thrombosis (Definite/Probable) [ Time Frame: 31 to 393 days ]
    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
  • Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable) [ Time Frame: 0 to 393 days ]
    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
  • Number of Subjects With Cumulative Stent/Scaffold Thrombosis (Definite/Probable) [ Time Frame: 0 to 1123 days ]
    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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetics of Everolimus in Absorb BVS in Patients With Coronary Artery Lesions
Official Title  ICMJE ABSORB III RCT Pharmacokinetics (PK) Sub-study
Brief 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.

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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Coronary Artery Disease
  • Coronary Artery Stenosis
  • Coronary Disease
  • Coronary Stenosis
Intervention  ICMJE Device: Coronary artery stenting: Absorb BVS
  • Scaffold diameters: 2.5, 3.0 and 3.5 mm
  • Scaffold lengths: 8, 12, 18, and 28 mm
Study Arms  ICMJE Experimental: Coronary artery stenting: Absorb BVS
Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)
Intervention: Device: Coronary artery stenting: Absorb BVS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 28, 2014)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 1, 2019
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02229864
Other Study ID Numbers  ICMJE 10-392 B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Abbott Medical Devices
Study Sponsor  ICMJE Abbott Medical Devices
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David G. Rizik, MD Scottsdale Healthcare, Scottsdale, AZ
Principal Investigator: Louis A. Cannon, MD Cardiac and Vascular Research Center of Northern Michigan Petoskey, MI
PRS Account Abbott Medical Devices
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP