ABSORB III Randomized Controlled Trial (RCT) (ABSORB-III)
Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease
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
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.
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
Experimental
Active Comparator
Absorb BVS
XIENCE
Subjects receiving Absorb BVS
Subjects receiving XIENCE V, XIENCE PRIME, or XIENCE Xpedition