THE ABSORB III RANDOMIZED CONTROLLED TRIAL (RCT)

This study is currently recruiting participants.
Verified November 2013 by Abbott Vascular
Sponsor:
Information provided by (Responsible Party):
Abbott Vascular
ClinicalTrials.gov Identifier:
NCT01751906
First received: December 13, 2012
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects with de novo Native Coronary Artery Lesions.


Condition Intervention
Coronary Artery Disease
Coronary Artery Stenosis
Coronary Disease
Coronary Stenosis
Device: Absorb BVS
Device: XIENCE V or XIENCE PRIME

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Official Title: A Clinical Evaluation of Absorb™ BVS, the Everolimus Eluting Bioresorbable Vascular Scaffold in the Treatment of Subjects With de Novo Native Coronary Artery Lesions.

Resource links provided by NLM:


Further study details as provided by Abbott Vascular:

Primary Outcome Measures:
  • ABSORB III: Target Lesion Failure (TLF) non-inferiority (NI) against the control. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TV-MI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR). This analysis will include ~2000 subjects.


Secondary Outcome Measures:
  • ABSORB Imaging Cohort: Major Secondary Endpoint 1: The normalized in-stent/scaffold mean lumen diameter change, between pre- and post-nitrate infusion by angiography. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Pooled angiographic subjects 200 from ABSORB III and 400 from ABSORB Japan.

  • ABSORB Imaging Cohort: Major Secondary Endpoint 2: The in-stent/scaffold mean lumen diameter change, between pre- and post-nitrate infusion at 3 years by angiography [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Pooled angiographic subjects 200 from ABSORB III and 400 from ABSORB Japan.

  • ABSORB Imaging Cohort: Major Secondary Endpoint 3: The in-stent/scaffold mean lumen area change, from post-procedure to 3 years by IVUS (mean lumen area measured after nitrate infusions). [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Pooled IVUS subjects 150 from ABSORB III and 150 from ABSORB Japan.

  • Acute Success: Device success (Device level analysis) [ Time Frame: From the start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Successful delivery and deployment of the study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable).

  • Acute Success: Procedural success (Subject level analysis) [ Time Frame: From the start of index procedure to end of index procedure ] [ Designated as safety issue: Yes ]
    Achievement of final in-scaffold/stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one study scaffold/stent at the intended target lesion and successful withdrawal of the delivery system for all target lesions without the occurrence of cardiac death, target vessel MI or repeat TLR during the hospital stay (maximum of 7 days).

  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death (Cardiac, Vascular, Non-cardiovascular) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Myocardial Infarction [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Myocardial Infarction [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    • Attributable to target vessel (TV-MI)
    • Not attributable to target vessel (NTV-MI)

  • Target Lesion Revascularization (TLR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    • Ischemia driven TLR (ID-TLR)
    • Non ID TLR (NID-TLR)

  • Target Lesion Revascularization (TLR) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    • Ischemia driven TLR (ID-TLR)
    • Non ID TLR (NID-TLR)

  • Target Lesion Revascularization (TLR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • Ischemia driven TLR (ID-TLR)
    • Non ID TLR (NID-TLR)

  • Target Lesion Revascularization (TLR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • Ischemia driven TLR (ID-TLR)
    • Non ID TLR (NID-TLR)

  • Target Lesion Revascularization (TLR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    • Ischemia driven TLR (ID-TLR)
    • Non ID TLR (NID-TLR)

  • Target Lesion Revascularization (TLR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    • Ischemia driven TLR (ID-TLR)
    • Non ID TLR (NID-TLR)

  • Target Lesion Revascularization (TLR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    • Ischemia driven TLR (ID-TLR)
    • Non ID TLR (NID-TLR)

  • Target Vessel Revascularization (TVR) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
    • ID TVR
    • Non ID TVR

  • Target Vessel Revascularization (TVR) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
    • ID TVR
    • Non ID TVR

  • Target Vessel Revascularization (TVR) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • ID TVR
    • Non ID TVR

  • Target Vessel Revascularization (TVR) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    • ID TVR
    • Non ID TVR

  • Target Vessel Revascularization (TVR) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    • ID TVR
    • Non ID TVR

  • Target Vessel Revascularization (TVR) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    • ID TVR
    • Non ID TVR

  • Target Vessel Revascularization (TVR) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    • ID TVR
    • Non ID TVR

  • All coronary revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • All coronary revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Death/All Myocardial Infarction (MI) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Death/All Myocardial Infarction (MI) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Death/All Myocardial Infarction (MI) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death/All Myocardial Infarction (MI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death/All Myocardial Infarction (MI) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death/All Myocardial Infarction (MI) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death/All Myocardial Infarction (MI) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/TV-MI/ID-TLR (TLF) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac Death/All MI/ID-TLR/ID-TVR, non TL (Target Vessel Failure, TVF) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Death/All MI/All revascularization [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Scaffold-Thrombosis / Stent Thrombosis (per ARC definition) [ Time Frame: acute, sub-acute, late and very late ] [ Designated as safety issue: Yes ]
  • Scaffold-Thrombosis / Stent Thrombosis (per ARC definition) [ Time Frame: Evidence (Definite and Probable) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2250
Study Start Date: December 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Absorb BVS
Subjects receiving Absorb BVS
Device: Absorb BVS
Subjects receiving Absorb BVS
Active Comparator: XIENCE V or XIENCE PRIME
Subjects receiving XIENCE V or XIENCE PRIME
Device: XIENCE V or XIENCE PRIME
Subjects receiving XIENCE V or XIENCE PRIME

Detailed Description:

ABSORB III Primary Objective: The pivotal trial to support the US pre-market approval (PMA) of Absorb BVS. ABSORB III will evaluate the safety and effectiveness of the Absorb BVS System compared to the XIENCE in the treatment of subjects, including those with diabetes mellitus, with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.

ABSORB III Secondary Objectives:

  • Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice.
  • Imaging Cohort Objective: To evaluate long-term vascular function and patency of the Absorb BVS treated segments compared to XIENCE treated segments in the treatment of subjects with ischemic heart disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  1. Subject must be at least 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. Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, post-infarct angina or silent ischemia) suitable for elective PCI. Subjects with stable angina or silent ischemia and < 70% diameter stenosis must have objectives sign of ischemia as determined by one of the following, echocardiogram, nuclear scan, ambulatory ECG or stress ECG). In the absence of noninvasive ischemia, FFR must be done and indicative of ischemia.
  4. Subject must be 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. For a female subject of childbearing potential a pregnancy test must be performed with negative results known within 7 days prior to the index procedure per site standard.
  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.

General Exclusion Criteria:

  1. Any surgery requiring general anesthesia or discontinuation of aspirin and/or an 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 CK and CK-MB have not returned to within normal limits at the time of 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% assessed by any quantitative method, including but not limited to echocardiography, MRI, Multiple-Gated Acquisition (MUGA) scan, contrast left ventriculography, PET scan, etc. LVEF may be obtained within 6 months prior to the procedure for subjects with stable CAD. For subjects presenting with ACS, LVEF must be assessed during the index hospitalization (which may include during the index procedure by contrast left ventriculography) but prior to randomization in order to confirm the subject's eligibility.
  8. Subject has undergone prior PCI within the target vessel during the last 12 months. Prior PCI within the non-target vessel or any peripheral intervention is acceptable if performed anytime >30 days before the index procedure, or between 24 hours and 30 days before the index procedure if successful and uncomplicated.
  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 autoimmune disease (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 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. This includes completion of Patient Reported Outcome instruments.
  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 who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include: Individuals with mental disability, persons in nursing homes, children, impoverished persons, persons in emergency situations, homeless persons, nomads, refugees, and those incapable of giving informed consent. Vulnerable populations also may include members of a group with a hierarchical structure such as university students, subordinate hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.

Angiographic Inclusion Criteria:

  1. One or two de novo target lesions:

    1. If there is one target lesion, a second non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful, uncomplicated result prior to randomization of the target lesion.
    2. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
    3. The definition of epicardial vessels means the LAD, LCX and 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 %DS of ≥ 50% and < 100% with a TIMI flow of ≥1 and one of the following: stenosis ≥ 70%, an abnormal functional test (e.g. fractional flow reserve, stress test), unstable angina or post-infarct angina.

    1. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.5 mm and ≤ 3.75 mm.
    2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
    3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.75 mm and ≤ 3.25 mm. The lesion length by visual estimation is ≥ 8 mm and ≤ 14 mm.

Angiographic Exclusion Criteria:

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

  1. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:

    • Residual %DS is a maximum of < 40% (per visual estimation), ≤ 20% is strongly recommended.
    • TIMI Grade-3 flow (per visual estimation).
    • No angiographic complications (e.g. distal embolization, side branch closure).
    • No dissections NHLBI grade D-F.
    • No chest pain lasting > 5 minutes.
    • No ST depression or elevation lasting > 5 minutes
  2. Lesion is located in left main.
  3. Aorto-ostial RCA lesion (within 3 mm of the ostium).
  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 pre-dilatation or protection guide wire.
  6. Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent:

    1. Extreme angulation (≥ 90°) proximal to or within the target lesion.
    2. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion.
    3. Moderate or heavy calcification proximal to or within the target lesion. If IVUS used, subject must be excluded if calcium ARC in the vessel prior to the lesion or within the lesion is ≥ 180°.
  7. Vessel contains thrombus as indicated in the angiographic images or by IVUS or 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 or XIENCE 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01751906

Contacts
Contact: Boris J Jelercic 408 845-3000 AbsorbRCT@abbott.com

  Hide Study Locations
Locations
United States, Alabama
Baptist Medical Center Princeton Recruiting
Birmingham, Alabama, United States, 35211
Presbyterian Hospital Recruiting
Birmingham, Alabama, United States, 35294
Thomas Hospital Recruiting
Fairhope, Alabama, United States, 36532
Baptist Medical Center South Recruiting
Montgomery, Alabama, United States, 36117
United States, Arizona
Chandler Regional Medical Center Recruiting
Gilbert, Arizona, United States, 85297
Scottsdale Healthcare Recruiting
Scottsdale, Arizona, United States, 85260
United States, Arkansas
Arkansas Heart Hospital Recruiting
Little Rock, Arkansas, United States, 72211
United States, California
John Muir Medical Center - Concord Campus Recruiting
Concord, California, United States, 94520
Washington Hospital Recruiting
Fremont, California, United States, 94538
Scripps Green Hospital Recruiting
La Jolla, California, United States, 92037
Providence Everett Med Ctr Recruiting
Modesto, California, United States, 95355
Eisenhower Medical Center, Desert Cardiology Center Recruiting
Rancho Mirage, California, United States, 92270
Sutter Memorial Hospital Recruiting
Sacramento, California, United States, 95819
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Santa Barbara Cottage Hospital Recruiting
Santa Barbara, California, United States, 93105
Abbott Vascular Recruiting
Santa Clara, California, United States, 95054
Contact: Boris J Jelercic    408-845-3000    AbsorbRCT@abbott.com   
Little Company Of Mary Hospital Recruiting
Torrance, California, United States, 90503
Torrance Memorial Medical Center Recruiting
Torrance, California, United States, 90505
United States, Colorado
Memorial Hospital Recruiting
Colorado Springs, Colorado, United States, 80909
Medical Center of the Rockies Recruiting
Fort Collins, Colorado, United States, 80538
United States, Connecticut
St. Vincent Medical Center Recruiting
Bridgeport, Connecticut, United States, 06606
University Hospital Recruiting
New Haven, Connecticut, United States, 06520
United States, Delaware
Christiana Care Health Services Recruiting
Newark, Delaware, United States, 19718
United States, District of Columbia
Washington Hospital Center Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
Brandon Regional Hospital Recruiting
Brandon, Florida, United States, 33511
Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Holy Cross Hospital Recruiting
Fort Lauderdale, Florida, United States, 33308
Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Baptist Medical Center - Downtown Recruiting
Jacksonville, Florida, United States, 33207
Palm Beach Gardens Medical Center Recruiting
Jupiter, Florida, United States, 33458
Baptist Hospital of Miami Recruiting
Miami, Florida, United States, 33176
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Munroe Regional Medical Center Recruiting
Ocala, Florida, United States, 34475
Florida Hospital Recruiting
Orlando, Florida, United States, 32803
Bay County Health System, LLC Recruiting
Panama City, Florida, United States, 32401
Baptist Hospital Recruiting
Pensacola, Florida, United States, 32501
Tallahassee Memorial Hospital Recruiting
Tallahassee, Florida, United States, 32308
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33609
Florida Hospital Tampa Recruiting
Tampa, Florida, United States, 33613
University Community Hospital Inc. Recruiting
Tampa, Florida, United States, 33613
United States, Georgia
Saint Joseph's Hospital of Atlanta Recruiting
Atlanta, Georgia, United States, 30342
Emory University Hospital Recruiting
Atlanta, Georgia, United States, 30322
Piedmont Hospital Atlanta Recruiting
Atlanta, Georgia, United States, 30309
Long Island Jewish Medical Center Recruiting
Augusta, Georgia, United States, 30901
Northeast Georgia Medical Center Recruiting
Gainesville, Georgia, United States, 30501
Wellstar Kennestone Hospital Recruiting
Marietta, Georgia, United States, 30060
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Sacred Heart Medical Center Recruiting
Oak Lawn, Illinois, United States, 60453
Saint Francis Medical Center Recruiting
Peoria, Illinois, United States, 61637
St. John's Hospital Recruiting
Springfield, Illinois, United States, 62701
United States, Indiana
Elkhart General Healthcare Recruiting
Elkhart, Indiana, United States, 46514
St. Vincent Heart Center of Indiana Recruiting
Indianapolis, Indiana, United States, 46290
Indiana University Health Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Methodist Hospital Recruiting
Indianapolis, Indiana, United States, 46202
Francisan St. Francis Health Recruiting
Indianapolis, Indiana, United States, 46237
United States, Iowa
Genesis Medical Center Recruiting
Davenport, Iowa, United States, 52803
Mercy Medical - Des Moines Recruiting
Des Moines, Iowa, United States, 50266
United States, Kansas
University of Kansas Hospital Authority Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
Central Baptist Hospital Recruiting
Lexington, Kentucky, United States, 40503
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
United States, Louisiana
Terrebonne General Medical Center Recruiting
Houma, Louisiana, United States, 70360
Willis Knighton Medical Center Recruiting
Shreveport, Louisiana, United States, 71105
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
United States, Maryland
Union Memorial Hospital Recruiting
Baltimore, Maryland, United States, 21218
Holy Spirit Hospital Recruiting
Baltimore, Maryland, United States, 21287
Peninsula Regional Medical Center Recruiting
Salisbury, Maryland, United States, 21804
Advocate Christ Medical Center Recruiting
Takoma Park, Maryland, United States, 20912
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
St. Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
Bay Regional Medical Center Recruiting
Bay City, Michigan, United States, 48708
Oakwood Hospital and Medical Center Recruiting
Dearborn, Michigan, United States, 48124
St John Hospital & Medical Center Recruiting
Detroit, Michigan, United States, 48236
St. Joseph's Hospital Health Center Recruiting
Detroit, Michigan, United States, 48236
Harper University Hospital Recruiting
Detroit, Michigan, United States, 48201
Henry Ford Hospital Heart and Vascular Institute Recruiting
Detroit, Michigan, United States, 48202
Borgess Medical Center Recruiting
Kalamazoo, Michigan, United States, 49048
Sparrow Hospital Recruiting
Lansing, Michigan, United States, 48912
Northern Michigan Hospital Recruiting
Petoskey, Michigan, United States, 49770
Beaumont Hospital Recruiting
Royal Oak, Michigan, United States, 48073
Munson Medical Center Recruiting
Traverse City, Michigan, United States, 49684
United States, Minnesota
Abbott Northwestern Hospital Recruiting
Minneapolis, Minnesota, United States, 55407
North Memorial Medical Center Recruiting
Minneapolis, Minnesota, United States, 55422
United States, Mississippi
North Mississippi Medical Center Recruiting
Tupelo, Mississippi, United States, 38801
United States, Missouri
Mercy General Hospital Recruiting
Springfield, Missouri, United States, 65807
Mercy Hospital - Springfield Recruiting
Springfield, Missouri, United States, 65807
Barnes Jewish Hospital Recruiting
St. Louis, Missouri, United States, 63110
St. Anthony's Medical Center Recruiting
St. Louis, Missouri, United States, 63128
United States, Montana
St. Patrick Hospital Recruiting
Missoula, Montana, United States, 59802
United States, Nebraska
Yale-New Haven Hospital Recruiting
Lincoln, Nebraska, United States, 68526
United States, New Hampshire
Dartmouth Hitchcock Memorial Hospital Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Intermountain Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Mother Frances Hospital Regional Healthcare Center Recruiting
Haddon Heights, New Jersey, United States, 08035
Morristown Memorial Hospital Recruiting
Morristown, New Jersey, United States, 07962
St. Joseph Hospital Recruiting
Neptune, New Jersey, United States, 07754
St. Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
United States, New Mexico
Bethesda North Hospital Recruiting
Albuquerque, New Mexico, United States, 87106
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Winthrop University Hospital Recruiting
Mineola, New York, United States, 11501
Johns Hopkins Hospital Recruiting
New Hyde Park, New York, United States, 11040
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Lenox Hill Hospital Recruiting
New York, New York, United States, 10021
New York Presbyterian Hospital-Cornell University Recruiting
New York, New York, United States, 10065
Washington Adventist Hospital Recruiting
New York, New York, United States, 10016
Mount Sinai Medical Center Recruiting
NY, New York, United States, 10029
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
New York University Medical Center Recruiting
Rochester, New York, United States, 14642
Stony Brook Hospital and Medical Center Recruiting
Stony Brook, New York, United States, 11794
United States, North Carolina
Carolinas Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Presbyterian Hospital Recruiting
Charlotte, North Carolina, United States, 28204
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Rex Hospital Recruiting
Raleigh, North Carolina, United States, 27607
Wake Med Recruiting
Raleigh, North Carolina, United States, 27610
Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Aultman Hospital Recruiting
Canton, Ohio, United States, 44708
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Good Samaritan Hospital Recruiting
Cincinnati, Ohio, United States, 45220
University Hospital Recruiting
Cincinnati, Ohio, United States, 45267
Nebraska Heart Hospital Recruiting
Cincinnati, Ohio, United States, 45242
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
University Hospital of Cleveland Recruiting
Cleveland, Ohio, United States, 44106
Riverside Methodist Hospital Recruiting
Columbus, Ohio, United States, 43214
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
EMH Regional Medical Center Recruiting
Elyria, Ohio, United States, 44035
Fairview General Hospital Recruiting
Fairview Park, Ohio, United States, 44126
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
The Toledo Hospital-Jobst Vascular Center Recruiting
Toledo, Ohio, United States, 43606
Mercy St. Vincent Medical Center Recruiting
Toledo, Ohio, United States, 43608
Genesis Good Samaritan Hospital Recruiting
Zanesville, Ohio, United States, 43701
United States, Oklahoma
Oklahoma Heart Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73120
Integris Baptist Medical Center, Inc. Recruiting
Oklahoma City, Oklahoma, United States, 73112
Hillcrest Medical Center Recruiting
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Cooper University Hospital Recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Abington Memorial Hospital Recruiting
Abington, Pennsylvania, United States, 19001
Memorial Medical Center Recruiting
Camp Hill, Pennsylvania, United States, 17011
Geisinger Medical Center Recruiting
Danville, Pennsylvania, United States, 17822
Doylestown Hospital Recruiting
Doylestown, Pennsylvania, United States, 18901
UPMC Hamot Medical Center Recruiting
Erie, Pennsylvania, United States, 16507
Pinnacle Health at Harrisburg Hospital Recruiting
Harrisburg, Pennsylvania, United States, 17101
St. Mary Medical Center Recruiting
Langhorne, Pennsylvania, United States, 19047
Pen Presbyterian Medical Center Recruiting
Philadelphia, Pennsylvania, United States, 19104
Pennsylvania Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
UPMC Presbyterian Shadyside Recruiting
Pittsburgh, Pennsylvania, United States, 15232
St. Joseph Medical Center Recruiting
Reading, Pennsylvania, United States, 19610
York Hospital Recruiting
York, Pennsylvania, United States, 17405
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
The Miriam Hospital Recruiting
Providence, Rhode Island, United States, 02906
United States, South Carolina
AnMed Health Recruiting
Anderson, South Carolina, United States, 29621
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Sisters of Charity Providence Hospitals Recruiting
Columbia, South Carolina, United States, 29204
St. Francis Health System Recruiting
Greenville, South Carolina, United States, 29605
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
United States, South Dakota
Sanford USD Medical Center Recruiting
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Wellmont Holston Valley Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
Turkey Creek Medical Center Recruiting
Knoxville, Tennessee, United States, 37934
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232-7235
United States, Texas
Northwest Texas Healthcare System Recruiting
Amarillo, Texas, United States, 79106
Seton Medical Center Austin Recruiting
Austin, Texas, United States, 78705
Baylor Heart and Vascular Hospital Recruiting
Dallas, Texas, United States, 75226
The Heart Hospital Baylor Plano Recruiting
Dallas, Texas, United States, 75093
St. Luke's Episcopal Hospital Recruiting
Houston, Texas, United States, 77030
Memorial Hermann-Hermann Hospital Recruiting
Houston, Texas, United States, 77030
Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Methodist TexSan Hospital Recruiting
San Antonio, Texas, United States, 78201
East Texas Medical Center Recruiting
Tyler, Texas, United States, 75701
Jersey Shore University Medical Center Recruiting
Tyler, Texas, United States, 75701
United States, Vermont
Fletcher Allen Health Care Recruiting
Burlington, Vermont, United States, 05401
United States, Virginia
Mary Washington Hospital Recruiting
Fredericksburg, Virginia, United States, 22401
Sentara Norfolk General Hospital Recruiting
Norfolk, Virginia, United States, 23507
Carilion Roanoke Memorial Recruiting
Roanoke, Virginia, United States, 24014
Winchester Medical Center Recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Overlake Hospital Medical Center Recruiting
Bellevue, Washington, United States, 98004
Strong Memorial Hospital Recruiting
Bellingham, Washington, United States, 98225
University of Alabama at Birmingham Recruiting
Everett, Washington, United States, 98201
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
United States, West Virginia
St. Mary's Medical Center Recruiting
Huntington, West Virginia, United States, 25701
United States, Wisconsin
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Abbott Vascular
Investigators
Principal Investigator: Stephen G Ellis, MD Cleveland Clinic, Cleveland OH
Principal Investigator: Dean J Kereiakes, MD The Christ Hospital, Cincinnati, OH
Study Chair: Gregg W Stone, MD Columbia University Medical Center, New York, NY
  More Information

No publications provided

Responsible Party: Abbott Vascular
ClinicalTrials.gov Identifier: NCT01751906     History of Changes
Other Study ID Numbers: 10-392
Study First Received: December 13, 2012
Last Updated: November 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott Vascular:
Absorb™ BVS
Angioplasty
Bioabsorbable
BVS
Bioresorbable
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

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Pathological Conditions, Anatomical
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Everolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014