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ABSORB III Randomized Controlled Trial (RCT) (ABSORB-III)

Primary Purpose

Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Absorb BVS
XIENCE
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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, fractional flow reserve (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.

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 ≥ 2.50 mm and ≤ 3.75 mm.
    2. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm.
    3. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (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.

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; 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% 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 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 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 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:

    1. Residual %DS is a maximum < 40% (per visual estimation), ≤ 20% is strongly recommended.
    2. TIMI Grade-3 flow (per visual estimation).
    3. No angiographic complications (e.g. distal embolization, side branch closure).
    4. No dissections NHLBI grade D-F.
    5. No chest pain lasting > 5 minutes.
    6. 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 dilatation
  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.

Sites / Locations

  • Baptist Medical Center Princeton
  • University of Alabama Hospital
  • Thomas Hospital
  • Baptist Medical Center South
  • Chandler Regional Medical Center
  • Banner Heart Hospital
  • Banner Good Samaritan Medical Center
  • Scottsdale Healthcare
  • Arkansas Heart Hospital
  • John Muir Medical Center - Concord Campus
  • Washington Hospital
  • Scripps Green Hospital
  • Scripps Memorial Hospital
  • Good Samaritan Hospital
  • Cedars-Sinai Medical Center
  • Sutter Central Valley Hospitals dba Memorial Medical Center
  • Mercy General Hospital
  • UC Davis Medical Center
  • Sutter Medical Center
  • Sharp Memorial Hospital
  • Santa Barbara Cottage Hospital
  • Stanford Hospital and Clinics
  • Little Company Of Mary Hospital
  • Torrance Memorial Medical Center
  • UCH-Memorial Health Systems
  • Medical Center of the Rockies
  • Yale-New Haven Hospital
  • St. Vincent's Medical Center
  • Christiana Care Health Services
  • Brandon Regional Hospital
  • Morton Plant Hospital
  • Holy Cross Hospital
  • Memorial Regional Hospital
  • St. Vincent's Medical Center
  • Baptist Medical Center - Downtown
  • University of Florida UF Health
  • University of Miami Hospital
  • Baptist Hospital of Miami
  • MediQuest Research Group Inc at Munroe Regional Medical Center
  • Florida Hospital
  • Palm Beach Gardens Medical Center
  • Bay County Health Systems
  • Baptist Hospital
  • Tallahassee Memorial Hospital
  • Tampa General Hospital
  • Florida Hospital Pepin Heart Institute
  • Piedmont Hospital
  • Emory University Hospital
  • Saint Joseph's Hospital of Atlanta
  • University Hospital
  • Northeast Georgia Medical Center
  • Wellstar Kennestone Hospital
  • Northwestern Memorial Hospital
  • Advocate Christ Medical Center
  • Saint Francis Medical Center
  • St. John's Hospital
  • Elkhart General Healthcare
  • Indiana University Health Methodist Hospital
  • Franciscan St. Francis Health
  • St. Vincent Heart Center of Indiana
  • Genesis Medical Center
  • Mercy Medical
  • The University of Kansas Hospital and Medical Center
  • Baptist Health Lexington
  • University of Kentucky Medical Center
  • Jewish Hospital
  • Eastern Maine Medical Center
  • Maine Medical Center
  • MedStar Washington Hospital Center
  • Union Memorial Hospital
  • Peninsula Regional Medical Center
  • Washington Adventist Hospital
  • Brigham and Women's Hospital
  • Boston University Medical Center
  • St. Elizabeth's Medical Center of Boston
  • UMass Memorial Medical Center
  • Bay Regional Medical Center
  • Oakwood Hospital and Medical Center
  • Harper University Hospital
  • Henry Ford Hospital
  • St. John Hospital & Medical Center
  • Borgess Medical Center
  • Sparrow Hospital
  • Northern Michigan Hospital
  • William Beaumont Hospital
  • Munson Medical Center
  • St. Joseph Mercy Hospital
  • Abbott Northwestern Hospital
  • North Memorial Medical Center
  • North Mississippi Medical Center Cardiology Associates Research, LLC
  • Boone Hospital Center
  • Barnes Jewish Hospital
  • St. Anthony's Medical Center
  • Mercy Hospital Springfield
  • St. Patrick Hospital
  • Nebraska Heart Hospital
  • Dartmouth-Hitchcock Medical Center
  • Englewood Hospital and Medical Center
  • Cooper University Hospital
  • Our Lady of Lourdes Medical Center
  • Morristown Medical Center
  • Jersey Shore University Medical Center
  • St. Joseph's Regional Medical Center
  • The Valley Hospital
  • Presbyterian Hospital
  • Montefiore Medical Center
  • St. Joseph's Hospital Health Center
  • Long Island Jewish Medical Center
  • Winthrop University Hospital
  • Mount Sinai Medical Center
  • Columbia University Medical Center
  • New York Presbyterian Hospital-Cornell University
  • Lennox Hill Hospital,
  • Rochester General Hospital
  • Strong Memorial Hospital
  • Stony Brook University Medical Center
  • Carolinas Medical Center
  • Presbyterian Hospital
  • Duke University Medical Center
  • Rex Hospital
  • WakeMed
  • Novant Health Forsyth Medical Center
  • Wake Forest University Baptist Medical Center
  • Aultman Hospital
  • University Hospital
  • The Christ Hospital
  • Tri-Health Good Samaritan Hospital
  • Bethesda North Hospital
  • University Hospitals of Cleveland
  • Cleveland Clinic
  • Ohio State University Medical Center
  • Riverside Methodist Hospital
  • EMH Healthcare
  • Cleveland Cln Fairview Hospital
  • Kettering Medical Center
  • The Toledo Hospital
  • Mercy St. Vincent's Medical Center
  • Genesis-Good Samaritan Hospital
  • Integris Baptist Medical Center
  • Oklahoma Heart Hospital
  • Hillcrest Medical Center
  • Providence St. Vincent Medical Center
  • PeaceHealth Sacred Heart Medical Center
  • Abington Memorial Hospital
  • Holy Spirit Hospital
  • Geisinger Medical Center
  • Doylestown Hospital
  • UPMC Hamot
  • St. Mary Medical Center
  • Penn Presbyterian Medical Center
  • Pennsylvania Hospital
  • Allegheny General Hospital
  • UPMC Presbyterian
  • UPMC Shadyside Hospital
  • Pinnacle Health at Harrisburg Hospital
  • St. Joseph Medical Center
  • York Hospital
  • Rhode Island Hospital
  • The Miriam Hospital
  • AnMed Health
  • Medical University of South Carolina
  • Sisters of Charity Providence Hospital
  • Greenville Memorial Hospital of the Greenville Health System
  • St. Francis Health System
  • Sanford USD Medical Center
  • Memorial Hospital
  • Wellmont Holston Valley Medical Center
  • Turkey Creek Medical Center
  • Vanderbilt University Medical Center
  • Northwest Texas Healthcare System
  • Seton Medical Center Austin
  • Baylor Jack and Jane Hamilton Heart and Vascular Hospital
  • St. Luke's Episcopal Hospital
  • The Methodist Hospital Research Institute
  • The Heart Hospital Baylor Plano
  • Methodist Texsan Hospital
  • East Texas Medical Center
  • Trinity Mother Frances Hospital Regional Healthcare Center
  • InterMountain Medical Center
  • Fletcher Allen Health Care
  • Inova Fairfax Hospital
  • Mary Washington Hospital
  • Sentara Norfolk General Hospital
  • Carilion Roanoke Memorial Hospital
  • Winchester Medical Center
  • St. Joseph Hospital
  • Providence Regional Medical Center Everett
  • Swedish Medical Center
  • St. Mary's Medical Center
  • Aurora St. Luke's Medical Center
  • Royal Brisbane and Women's Hospital
  • St. Vincent's Hospital Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Absorb BVS

XIENCE

Arm Description

Subjects receiving Absorb BVS

Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition

Outcomes

Primary Outcome Measures

Number of Cardiac Death/TV-MI/ID-TLR (TLF)
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).

Secondary Outcome Measures

Number of Participants With Powered Secondary Endpoint: Angina
Angina is defined as the first adverse event resulting in the site diagnosis of angina.
Number of Participants With Powered Secondary Endpoint: All Revascularization
This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.
Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)
This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.
Acute Success- Device Success (Lesion Level Analysis)
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 quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Acute Success: Procedural Success (Subject Level Analysis)
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).
Number of Death (Cardiac, Vascular, Non-cardiovascular)
DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Number of Participants With All Myocardial Infarction (MI)
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Number of Participants With All Target Lesion Revascularization (TLR)
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Number of Participants With All Revascularization
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Number of Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Cardiac Death/All MI
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Number of Participants With Target Vessel Failure (TVF)
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Number of Death/All MI/All Revascularization (DMR)
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Number of Participants With Subacute Stent/Scaffold Thrombosis
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Number of Participants With Cumulative Stent/Scaffold Thrombosis
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Pre-Procedure Minimum Lumen Diameter (MLD)
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
Pre-Procedure Percent Diameter Stenosis (%DS)
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Post-Procedure In-Segment Minimum Lumen Diameter (MLD)
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Post-Procedure In-Segment Percent Diameter Stenosis (%DS)
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Post-Procedure In-Device Minimum Lumen Diameter (MLD)
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold
Post-Procedure In-Device Percent Diameter Stenosis (%DS)
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Post-Procedure In-Device Acute Gain
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)
Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects. Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.
Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions

Full Information

First Posted
December 13, 2012
Last Updated
October 6, 2023
Sponsor
Abbott Medical Devices
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1. Study Identification

Unique Protocol Identification Number
NCT01751906
Brief Title
ABSORB III Randomized Controlled Trial (RCT)
Acronym
ABSORB-III
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.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The ABSORB III RCT is a prospective randomized, single-blind, multi-center trial. It is the pivotal trial to support the US pre-market approval (PMA) of Absorb™ Bioresorbable Vascular Scaffold (BVS). The ABSORB III includes additional two trials i.e. ABSORB III PK (pharmacokinetics) sub-study and ABSORB IV RCT trial which are maintained under one protocol because both trial designs are related, ABSORB IV is the continuation of ABSORB III and the data from ABSORB III and ABSORB IV will be pooled to support the ABSORB IV primary endpoint. Both the trials will evaluate the safety and effectiveness of Absorb BVS.
Detailed Description
ABSORB III RCT: A. 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. B. Powered Secondary Objectives: Lead-In Phase Objective: To evaluate the applicability and transferability of the didactic Absorb BVS physician training plan to US clinical practice. The lead-in phase is a non-randomized, single-arm, open label group of up to 50 subjects treated with Absorb BVS at up to 35 US sites. The Lead-In phase will enroll/register subjects prior to the randomization phase of ABSORB III. The Lead-In Phase allows the treatment of up to two de novo native coronary artery lesions in different epicardial vessels with reference vessel diameter (RVD) ≥ 2.75 mm to ≤ 3.25 mm and lesion lengths ≥ 8 to ≤ 14 mm. 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. The imaging cohort-phase is a prospective, randomized (2:1 Absorb BVS to XIENCE), single-blind, multi-center trial, registering approximately 200 subjects. This includes 150 subjects for the angiographic/intravascular ultrasound (IVUS) endpoints analysis and approximately 50 subjects for optical coherence tomography (OCT) endpoints analysis. The 200 subjects are separate from the 2000 subjects included in the primary analysis. Data from two powered secondary endpoints from this cohort will support label claims of superiority of Absorb BVS as compared to XIENCE specific to vasomotion and late lumen enlargement. All other subjects in ABSORB III unless specified will receive treatment of up to two de novo native coronary artery lesions in different epicardial vessels with RVD ≥ 2.5 mm to ≤ 3.75 mm and lesion lengths ≤ 24 mm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Stenosis
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
2008 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Absorb BVS
Arm Type
Experimental
Arm Description
Subjects receiving Absorb BVS
Arm Title
XIENCE
Arm Type
Active Comparator
Arm Description
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition
Intervention Type
Device
Intervention Name(s)
Absorb BVS
Intervention Description
Scaffold diameters: 2.5, 3.0 and 3.5 mm Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter. The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study. Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Intervention Type
Device
Intervention Name(s)
XIENCE
Intervention Description
Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only). Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.
Primary Outcome Measure Information:
Title
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description
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).
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Number of Participants With Powered Secondary Endpoint: Angina
Description
Angina is defined as the first adverse event resulting in the site diagnosis of angina.
Time Frame
1 year
Title
Number of Participants With Powered Secondary Endpoint: All Revascularization
Description
This powered secondary endpoint is intended to assess all revascularization at 1 year and test for superiority of Absorb BVS to XIENCE. All revascularizations are comprised of TLR, TVR excluding TLR, and non-TVR.
Time Frame
1 year
Title
Number of Participants With Powered Secondary Endpoint: Ischemia Driven Target Vessel Revascularization (ID-TVR)
Description
This powered secondary endpoint is intended to assess all ID-TVR at 1 year and test for superiority of Absorb BVS to XIENCE.
Time Frame
1 year
Title
Acute Success- Device Success (Lesion Level Analysis)
Description
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 quantitative coronary angiography (QCA) (by visual estimation if QCA unavailable). When bailout scaffold/stent is used, the success or failure of the bailout scaffold/stent delivery and deployment is not one of the criteria for device success.
Time Frame
On day 0 (the day of procedure)
Title
Acute Success: Procedural Success (Subject Level Analysis)
Description
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).
Time Frame
On day 0 (the day of procedure)
Title
Number of Death (Cardiac, Vascular, Non-cardiovascular)
Description
DEATH (Per ARC Circulation) : All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac. Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma.
Time Frame
0 to 5 years
Title
Number of Participants With All Myocardial Infarction (MI)
Description
Attributable to target vessel (TV-MI) Not attributable to target vessel (NTV-MI)
Time Frame
0 to 5 years
Title
Number of Participants With All Target Lesion Revascularization (TLR)
Description
TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion. All TLR should be classified prospectively as ischemia driven (ID-TLR) or not ischemia driven (NID-TLR) by the investigator prior to repeat angiography. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
Time Frame
0 to 5 years
Title
Number of Participants With All Target Vessel Revascularization (TVR) Excluding Target Lesion Revascularization (TLR)
Description
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself.
Time Frame
0 to 5 years
Title
Number of Participants With All Revascularization
Description
All revascularization endpoint is comprised of TLR, TVR excluding TLR, and non-TVR.
Time Frame
0 to 5 years
Title
Number of Death/All MI
Description
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame
0 to 5 years
Title
Number of Cardiac Death/All MI
Description
All deaths includes Cardiac death: Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Vascular death: Death due to non-coronary vascular causes such as cerebrovascular disease, pulmonary embolism, ruptured aortic aneurysm, dissecting aneurysm, or other vascular cause. Non-cardiovascular death: Any death not covered by the above definitions such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. Myocardial Infarction (MI) - Q wave MI: Development of new, pathological Q wave on the ECG. -Non-Q wave MI: Those MIs which are not Q-wave MI
Time Frame
0 to 5 years
Title
Number of Cardiac Death/TV-MI/ID-TLR (TLF)
Description
Target Lesion Failure is composite of Cardiac death/ Target Vessel Myocardial Infarction (TV-MI)/ Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
0 to 5 years
Title
Number of Cardiac Death/All MI/ID-TLR (Major Adverse Cardiac Events-MACE)
Description
Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial infarction, and ischemic driven target lesion revascularization (ID-TLR).
Time Frame
0 to 5 years
Title
Number of Participants With Target Vessel Failure (TVF)
Description
Target Vessel Failure (TVF) is the composite of Cardiac Death, Myocardial infarction (MI) or Ischemic-Driven Target Vessel Revascularization (ID-TVR).
Time Frame
0 to 5 years
Title
Number of Death/All MI/All Revascularization (DMR)
Description
DMR is the composite of All Death, All Myocardial infarction (MI) and All Revascularization.
Time Frame
0 to 5 years
Title
Number of Participants With Acute Stent/Scaffold Thrombosis (Per ARC Definition)
Description
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame
≤ 1 Day
Title
Number of Participants With Acute/Subacute Stent/Scaffold Thrombosis (Per ARC Definition)
Description
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame
0 to 30 Days
Title
Number of Participants With Subacute Stent/Scaffold Thrombosis
Description
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame
>1 to 30 Days
Title
Number of Participants With Late Stent/Scaffold Thrombosis (Per ARC Definition)
Description
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame
31 to 365 Days
Title
Number of Participants With Very Late Stent /Scaffold Thrombosis (Per ARC Definition)
Description
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame
366 to 393 Days
Title
Number of Participants With Cumulative Stent/Scaffold Thrombosis
Description
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame
0 to 1853 Days
Title
Pre-Procedure Minimum Lumen Diameter (MLD)
Description
Angiographic endpoint Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen.
Time Frame
< or = 1 day
Title
Pre-Procedure Percent Diameter Stenosis (%DS)
Description
Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame
< or = 1 day
Title
Post-Procedure In-Segment Minimum Lumen Diameter (MLD)
Description
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Time Frame
≤ 7 days post index procedure
Title
Post-Procedure In-Segment Percent Diameter Stenosis (%DS)
Description
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA). In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold.
Time Frame
≤ 7 days post index procedure
Title
Post-Procedure In-Device Minimum Lumen Diameter (MLD)
Description
Angiographic endpoint. Minimum lumen diameter is defined as the shortest diameter through the center point of the lumen. In- Segment is defined as, within the margins of the stent or scaffold and 5 mm proximal and 5 mm distal to the stent or scaffold
Time Frame
≤ 7 days post index procedure
Title
Post-Procedure In-Device Percent Diameter Stenosis (%DS)
Description
Angiographic endpoint. Percent Diameter Stenosis is defined as the value calculated as 100 * (1 - Minimum Luminal Diameter (MLD)/Reference vessel diameter (RVD)) using the mean values from two orthogonal views (when possible) by quantitative coronary angiography (QCA).
Time Frame
≤ 7 days post index procedure
Title
Post-Procedure In-Device Acute Gain
Description
The acute gain was defined as the difference between post- and pre procedural minimal lumen diameter (MLD).
Time Frame
≤ 7 days post index procedure
Title
Powered Imaging Cohort Secondary Endpoint: The Instent/Scaffold Mean Lumen Area Change, From Post Procedure to 3 Years by Intravascular Ultrasound (IVUS)
Description
Mean lumen area measured after nitrate infusions, superiority test, ~300 pooled subjects. Pooled IVUS subjects (~300 subjects): 150 subjects from the Imaging Cohort of ABSORB III RCT and 150 subjects from ABSORB Japan RCT.
Time Frame
From Post procedure to 3 Years
Title
Optical Coherence Tomography (OCT) Endpoint: Mean Neointimal Area (NIA)
Description
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame
3 Years
Title
Optical Coherence Tomography (OCT) Endpoint: Mean Device Area, Adluminal
Description
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame
3 Years
Title
Optical Coherence Tomography (OCT) Endpoint: Mean Lumen Area
Description
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame
3 Years
Title
Optical Coherence Tomography (OCT) Endpoint: Minimal Lumen Area
Description
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame
3 Years
Title
Optical Coherence Tomography (OCT) Endpoint: Percentage of Malapposition Struts
Description
All OCT endpoints will be collected for within the device and within the treated segment: Descriptive analysis of strut, lesion and vessel morphology Mean neointimal area (NIA) - Apposed to the vessel wall with neointimal coverage Apposed to vessel wall without neointimal coverage Incomplete apposition to vessel wall with neointimal coverage Incomplete apposition to vessel wall without neointimal coverage Lumen area/volume stenosis % Mean/minimal device area Mean/minimal luminal area/volume Mean strut area/volume Persisting incomplete apposition, late incomplete apposition at 3 years (if analyzable) OCT analysis for subjects with jailed side branch Descriptive analyses from 3-dimensional OCT reconstructions
Time Frame
3 Years
Other Pre-specified Outcome Measures:
Title
Patient Reported Outcomes (PRO): Overall Health Status
Description
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Time Frame
Baseline
Title
Patient Reported Outcomes (PRO): Overall Health Status
Description
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Time Frame
1 month
Title
Patient Reported Outcomes (PRO): Overall Health Status
Description
Overall health status assessed using the EuroQoL 5D (EQ-5D™). EQ-5D: Scale range: 0 to 1 Higher values represent better outcomes Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Subscale scores are summed to obtain total/overall health status. A scoring algorithm was used to combine the sub-scores from each of the 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), and generate a single index ranging from 0 to 1
Time Frame
12 months
Title
Patient Reported Outcomes (PRO): Anxiety
Description
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
Time Frame
Baseline
Title
Patient Reported Outcomes (PRO): Anxiety
Description
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
Time Frame
1 month
Title
Patient Reported Outcomes (PRO): Anxiety
Description
Anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7). GAD-7: Scale range: 0 to 21 Lower values represent better outcomes No subscales
Time Frame
12 months
Title
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
Description
Disease-Specific quality of life assessed using the Seattle Angina Questionnaire (SAQ) Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Time Frame
Baseline
Title
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
Description
Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Time Frame
1 month
Title
Patient Reported Outcomes (PRO): Disease-Specific Quality of Life
Description
Disease-Specific quality of life in hospital baseline and at 1 year assessed using the Seattle Angina Questionnaire (SAQ). Seattle Angina Questionnaire (SAQ): Each scale is transformed to a score of 0 to 100, where higher scores indicate better function (eg, less physical limitation, less angina, and better quality of life).
Time Frame
12 months
Title
Patient Reported Outcomes (PRO): Dyspnea Severity
Description
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
Time Frame
Baseline
Title
Patient Reported Outcomes (PRO): Dyspnea Severity
Description
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
Time Frame
1 month
Title
Patient Reported Outcomes (PRO): Dyspnea Severity
Description
Dyspnea severity assessed using the Rose Dyspnea Scale (RDS). Rose Dyspnea Scale: Scale range: 0 to 4 Lower values represent better outcomes (higher scores indicate worse dyspnea) No subscales
Time Frame
12 months
Title
Landmark Analysis on TLF and Components
Description
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
3-4 years
Title
Landmark Analysis on TLF and Components
Description
TLF is defined as composite of Cardiac Death, Myocardial Infarction (per protocol-defined MI definition), attributable to Target Vessel (TVMI), or Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time Frame
3-5 years
Title
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Description
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame
3-4 years
Title
Landmark Analysis on Cumulative Scaffold Thrombosis/Stent Thrombosis (Per ARC Definition, Definite and Probable)
Description
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. Timing : Acute : 0 - 24 hours post stent implantation; Subacute : >24 hours - 30 days post stent implantation; Late : 30 days - 1 year post stent implantation; Very late : >1 year post stent implantation. Evidence: Definite stent thrombosis is considered to have occurred by either angiographic or pathologic confirmation. Probable stent thrombosis is considered to have occurred after intracoronary stenting in case of Any unexplained death within the first 30 days or Irrespective of the time after the index procedure, any MI that is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.
Time Frame
3-5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
General Inclusion Criteria: Subject must be at least 18 years of age. Subject or a legally authorized representative must provide written Informed Consent prior to any study related procedure, per site requirements. 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, fractional flow reserve (FFR) must be done and indicative of ischemia. Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery. 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. 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. 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: One or two de novo target lesions: 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. If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria. 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. 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. Lesion(s) must be located in a native coronary artery with RVD by visual estimation of ≥ 2.50 mm and ≤ 3.75 mm. Lesion(s) must be located in a native coronary artery with length by visual estimation of ≤ 24 mm. For Lead-In subjects with 3.0x18 mm Absorb BVS: lesions (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. General Exclusion Criteria: Any surgery requiring general anesthesia or discontinuation of aspirin and/or an ADP antagonist is planned within 12 months after the procedure. 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. 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. 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; or subject with stable angina or silent ischemia has CK-MB that is greater than normal limits at the time of the index procedure. 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. Subject has a cardiac arrhythmia as identified at the time of screening for which at least one of the following criteria is met: Subject requires coumadin or any other agent for chronic oral anticoagulation. Subject is likely to become hemodynamically unstable due to their arrhythmia. Subject has poor survival prognosis due to their arrhythmia. 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. 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. Subject requires future staged PCI either in target or non-target vessels or subject requires future peripheral interventions < 30 days after the index procedure Subject has received any solid organ transplants or is on a waiting list for any solid organ transplants. At the time of screening, the subject has a malignancy that is not in remission. 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. Subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy), or the chest/mediastinum. Subject is receiving or will require chronic anticoagulation therapy (e.g., coumadin, dabigatran, apixaban, rivaroxaban or any other agent for any reason). Subject has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3. Subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B. Subject has renal insufficiency as defined as an estimated GFR < 30 ml/min/1.73m2 or dialysis at the time of screening. 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. 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.). 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. Subject has life expectancy < 5 years for any non-cardiac cause or cardiac cause. 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. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint. 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 Exclusion Criteria: All exclusion criteria apply to the target lesion(s) or target vessel(s). Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes: Residual %DS is a maximum < 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. Lesion is located in left main. Aorto-ostial RCA lesion (within 3 mm of the ostium). Lesion located within 3 mm of the origin of the LAD or LCX. Lesion involving a bifurcation with a: side branch ≥ 2 mm in diameter, or side branch with either an ostial or non-ostial lesion with diameter stenosis > 50%, or side branch requiring dilatation Anatomy proximal to or within the lesion that may impair delivery of the Absorb BVS or XIENCE stent: Extreme angulation (≥ 90°) proximal to or within the target lesion. Excessive tortuosity (≥ two 45° angles) proximal to or within the target lesion. 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°. Vessel contains thrombus as indicated in the angiographic images or by IVUS or OCT. Lesion or vessel involves a myocardial bridge. 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. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion. Target lesion located within an arterial or saphenous vein graft or distal to any arterial or saphenous vein graft.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen G Ellis, MD
Organizational Affiliation
Cleveland Clinic, Cleveland OH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dean J Kereiakes, MD
Organizational Affiliation
The Christ Hospital, Cincinnati, OH
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gregg W Stone, MD
Organizational Affiliation
Columbia University Medical Center, New York, NY
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jennifer McMeans Jones
Organizational Affiliation
Abbott Medical Devices
Official's Role
Study Director
Facility Information:
Facility Name
Baptist Medical Center Princeton
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35211
Country
United States
Facility Name
University of Alabama Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Thomas Hospital
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Facility Name
Baptist Medical Center South
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36117
Country
United States
Facility Name
Chandler Regional Medical Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85297
Country
United States
Facility Name
Banner Heart Hospital
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Facility Name
Banner Good Samaritan Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Scottsdale Healthcare
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Facility Name
Arkansas Heart Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72211
Country
United States
Facility Name
John Muir Medical Center - Concord Campus
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Washington Hospital
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Scripps Green Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Scripps Memorial Hospital
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Good Samaritan Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90043
Country
United States
Facility Name
Sutter Central Valley Hospitals dba Memorial Medical Center
City
Modesto
State/Province
California
ZIP/Postal Code
95355
Country
United States
Facility Name
Mercy General Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Sutter Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95819
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Santa Barbara Cottage Hospital
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Little Company Of Mary Hospital
City
Torrance
State/Province
California
ZIP/Postal Code
90503
Country
United States
Facility Name
Torrance Memorial Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
UCH-Memorial Health Systems
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Medical Center of the Rockies
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80538
Country
United States
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
St. Vincent's Medical Center
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
Brandon Regional Hospital
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Holy Cross Hospital
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
St. Vincent's Medical Center
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Baptist Medical Center - Downtown
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Florida UF Health
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
University of Miami Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
MediQuest Research Group Inc at Munroe Regional Medical Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Palm Beach Gardens Medical Center
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33410
Country
United States
Facility Name
Bay County Health Systems
City
Panama City
State/Province
Florida
ZIP/Postal Code
32401
Country
United States
Facility Name
Baptist Hospital
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Facility Name
Tallahassee Memorial Hospital
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Florida Hospital Pepin Heart Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Saint Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
University Hospital
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30901
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Saint Francis Medical Center
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61614
Country
United States
Facility Name
St. John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Elkhart General Healthcare
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46514
Country
United States
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Franciscan St. Francis Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
St. Vincent Heart Center of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Genesis Medical Center
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Mercy Medical
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
The University of Kansas Hospital and Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66106
Country
United States
Facility Name
Baptist Health Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
University of Kentucky Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Jewish Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Union Memorial Hospital
City
Hyattsville
State/Province
Maryland
ZIP/Postal Code
20782
Country
United States
Facility Name
Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21804
Country
United States
Facility Name
Washington Adventist Hospital
City
Takoma Park
State/Province
Maryland
ZIP/Postal Code
20912
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
St. Elizabeth's Medical Center of Boston
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
UMass Memorial Medical Center
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
Bay Regional Medical Center
City
Bay City
State/Province
Michigan
ZIP/Postal Code
48708
Country
United States
Facility Name
Oakwood Hospital and Medical Center
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Harper University Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
St. John Hospital & Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
Northern Michigan Hospital
City
Petoskey
State/Province
Michigan
ZIP/Postal Code
49770
Country
United States
Facility Name
William Beaumont Hospital
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48703
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
North Mississippi Medical Center Cardiology Associates Research, LLC
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Boone Hospital Center
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Anthony's Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
St. Patrick Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Nebraska Heart Hospital
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68526
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Englewood Hospital and Medical Center
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Cooper University Hospital
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Our Lady of Lourdes Medical Center
City
Haddon Heights
State/Province
New Jersey
ZIP/Postal Code
08035
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Jersey Shore University Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07753
Country
United States
Facility Name
St. Joseph's Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
The Valley Hospital
City
Ridgewood
State/Province
New Jersey
ZIP/Postal Code
07450
Country
United States
Facility Name
Presbyterian Hospital
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
St. Joseph's Hospital Health Center
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Facility Name
Long Island Jewish Medical Center
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Presbyterian Hospital-Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Lennox Hill Hospital,
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Rochester General Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14621
Country
United States
Facility Name
Strong Memorial Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14627
Country
United States
Facility Name
Stony Brook University Medical Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27110
Country
United States
Facility Name
Rex Hospital
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
WakeMed
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27610
Country
United States
Facility Name
Novant Health Forsyth Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Wake Forest University Baptist Medical Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Aultman Hospital
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
University Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Tri-Health Good Samaritan Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Facility Name
Bethesda North Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
University Hospitals of Cleveland
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
EMH Healthcare
City
Elyria
State/Province
Ohio
ZIP/Postal Code
44035
Country
United States
Facility Name
Cleveland Cln Fairview Hospital
City
Fairview Park
State/Province
Ohio
ZIP/Postal Code
44126
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
The Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Mercy St. Vincent's Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Genesis-Good Samaritan Hospital
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Integris Baptist Medical Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Hillcrest Medical Center
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Providence St. Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
PeaceHealth Sacred Heart Medical Center
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97477
Country
United States
Facility Name
Abington Memorial Hospital
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Holy Spirit Hospital
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Doylestown Hospital
City
Doylestown
State/Province
Pennsylvania
ZIP/Postal Code
18901
Country
United States
Facility Name
UPMC Hamot
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16550
Country
United States
Facility Name
St. Mary Medical Center
City
Langhorne
State/Province
Pennsylvania
ZIP/Postal Code
19047
Country
United States
Facility Name
Penn Presbyterian Medical Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Pennsylvania Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
UPMC Shadyside Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Facility Name
Pinnacle Health at Harrisburg Hospital
City
Wormleysburg
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
St. Joseph Medical Center
City
Wyomissing
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
York Hospital
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17405
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
AnMed Health
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Sisters of Charity Providence Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Greenville Memorial Hospital of the Greenville Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
St. Francis Health System
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Memorial Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Wellmont Holston Valley Medical Center
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Turkey Creek Medical Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37934
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Northwest Texas Healthcare System
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Facility Name
Seton Medical Center Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Baylor Jack and Jane Hamilton Heart and Vascular Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
St. Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Methodist Hospital Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
Methodist Texsan Hospital
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78201
Country
United States
Facility Name
East Texas Medical Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Trinity Mother Frances Hospital Regional Healthcare Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
InterMountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Fletcher Allen Health Care
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Mary Washington Hospital
City
Fredericksburg
State/Province
Virginia
ZIP/Postal Code
22401
Country
United States
Facility Name
Sentara Norfolk General Hospital
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Winchester Medical Center
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
St. Joseph Hospital
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Providence Regional Medical Center Everett
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
St. Mary's Medical Center
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Facility Name
Aurora St. Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
St. Vincent's Hospital Melbourne
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
33893022
Citation
Nishi T, Okada K, Kitahara H, Kameda R, Ikutomi M, Imura S, Hollak MB, Yock PG, Popma JJ, Kusano H, Cheong WF, Sudhir K, Fitzgerald PJ, Ellis SG, Kereiakes DJ, Stone GW, Honda Y, Kimura T; ABSORB III and ABSORB Japan Investigators. Intravascular ultrasound predictors of long-term outcomes following ABSORB bioresorbable scaffold implantation: A pooled analysis of the ABSORB III and ABSORB Japan trials. J Cardiol. 2021 Sep;78(3):224-229. doi: 10.1016/j.jjcc.2021.03.005. Epub 2021 Apr 21.
Results Reference
derived
PubMed Identifier
31561250
Citation
Stone GW, Kimura T, Gao R, Kereiakes DJ, Ellis SG, Onuma Y, Chevalier B, Simonton C, Dressler O, Crowley A, Ali ZA, Serruys PW. Time-Varying Outcomes With the Absorb Bioresorbable Vascular Scaffold During 5-Year Follow-up: A Systematic Meta-analysis and Individual Patient Data Pooled Study. JAMA Cardiol. 2019 Dec 1;4(12):1261-1269. doi: 10.1001/jamacardio.2019.4101.
Results Reference
derived
PubMed Identifier
31553222
Citation
Kereiakes DJ, Ellis SG, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, Tan SH, Ediebah DE, Simonton C, Stone GW; ABSORB III Investigators. Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial. Circulation. 2019 Dec 3;140(23):1895-1903. doi: 10.1161/CIRCULATIONAHA.119.042584. Epub 2019 Sep 25.
Results Reference
derived
PubMed Identifier
29100702
Citation
Kereiakes DJ, Ellis SG, Metzger C, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. 3-Year Clinical Outcomes With Everolimus-Eluting Bioresorbable Coronary Scaffolds: The ABSORB III Trial. J Am Coll Cardiol. 2017 Dec 12;70(23):2852-2862. doi: 10.1016/j.jacc.2017.10.010. Epub 2017 Oct 31.
Results Reference
derived
PubMed Identifier
29089314
Citation
Ali ZA, Gao R, Kimura T, Onuma Y, Kereiakes DJ, Ellis SG, Chevalier B, Vu MT, Zhang Z, Simonton CA, Serruys PW, Stone GW. Three-Year Outcomes With the Absorb Bioresorbable Scaffold: Individual-Patient-Data Meta-Analysis From the ABSORB Randomized Trials. Circulation. 2018 Jan 30;137(5):464-479. doi: 10.1161/CIRCULATIONAHA.117.031843. Epub 2017 Oct 31.
Results Reference
derived
PubMed Identifier
28427593
Citation
Baron SJ, Lei Y, Chinnakondepalli K, Vilain K, Magnuson EA, Kereiakes DJ, Ellis SG, Stone GW, Cohen DJ; ABSORB III Investigators. Economic Outcomes of Bioresorbable Vascular Scaffolds Versus Everolimus-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention: 1-Year Results From the ABSORB III Trial. JACC Cardiovasc Interv. 2017 Apr 24;10(8):774-782. doi: 10.1016/j.jcin.2017.01.022.
Results Reference
derived
PubMed Identifier
26825231
Citation
Stone GW, Gao R, Kimura T, Kereiakes DJ, Ellis SG, Onuma Y, Cheong WF, Jones-McMeans J, Su X, Zhang Z, Serruys PW. 1-year outcomes with the Absorb bioresorbable scaffold in patients with coronary artery disease: a patient-level, pooled meta-analysis. Lancet. 2016 Mar 26;387(10025):1277-89. doi: 10.1016/S0140-6736(15)01039-9. Epub 2016 Jan 27.
Results Reference
derived
PubMed Identifier
26457558
Citation
Ellis SG, Kereiakes DJ, Metzger DC, Caputo RP, Rizik DG, Teirstein PS, Litt MR, Kini A, Kabour A, Marx SO, Popma JJ, McGreevy R, Zhang Z, Simonton C, Stone GW; ABSORB III Investigators. Everolimus-Eluting Bioresorbable Scaffolds for Coronary Artery Disease. N Engl J Med. 2015 Nov 12;373(20):1905-15. doi: 10.1056/NEJMoa1509038. Epub 2015 Oct 12.
Results Reference
derived
PubMed Identifier
26386787
Citation
Kereiakes DJ, Ellis SG, Popma JJ, Fitzgerald PJ, Samady H, Jones-McMeans J, Zhang Z, Cheong WF, Su X, Ben-Yehuda O, Stone GW. Evaluation of a fully bioresorbable vascular scaffold in patients with coronary artery disease: design of and rationale for the ABSORB III randomized trial. Am Heart J. 2015 Oct;170(4):641-651.e3. doi: 10.1016/j.ahj.2015.07.013. Epub 2015 Jul 26.
Results Reference
derived

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ABSORB III Randomized Controlled Trial (RCT)

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