ABSORB II Randomized Controlled Trial

ABSORB II RANDOMIZED CONTROLLED TRIAL A Clinical Evaluation to Compare the Safety, Efficacy and Performance of ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System Against XIENCE Everolimus Eluting Coronary Stent System in the Treatment of Subjects With Ischemic Heart Disease Caused by de Novo Native Coronary Artery Lesions

Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE)

In the USA, ABSORB BVS is currently in development at Abbott Vascular. Not available for sale in the US.

Inclusion Criteria:

General Inclusion Criteria

• Subject must be at least 18 years of age and less than 85 years of age.
• Subject must agree not to participate in any other clinical investigation for a period of three years following the index procedure. This includes clinical trials of medication and invasive procedures. Questionnaire-based studies, or other studies that are non-invasive and do not require medication are allowed.
• Subject is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ABSORB BVS system and he/she or his/her legally authorized representative provides written informed consent prior to any Clinical Investigation related procedure, as approved by the appropriate Ethics Committee.
• Subject must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia).
• Subject must be an acceptable candidate for coronary artery bypass graft (CABG) surgery
• Subject must agree to undergo all clinical investigation plan-required follow-up visits, exercise testing, blood draw as well as adherence to European Society of Cardiology Guidelines and completion of quality of life questionnaires and of a subject diary to collect information including but not limited to tobacco usage, food intake, daily exercise and body weight

Angiographic Inclusion Criteria

• One or two de novo native lesions each located in a different epicardial vessel.
• If two treatable lesions meet the eligibility criteria, they must be in separate major epicardial vessels (left anterior descending (LAD) with septal and diagonal branches, left circumflex artery (LCX) with obtuse marginal and/or ramus intermedius branches and right coronary artery (RCA) and any of its branches).
• Lesion(s) must have a visually estimated diameter stenosis of ≥50% and <100% with a TIMI flow of ≥1.
• Lesion(s) must be located in a native coronary artery with Dmax by on-line quantitative coronary angiography (QCA) of ≥2.25 mm and ≤3.8 mm.
• Lesion(s) must be located in a native coronary artery with lesion(s) length by on-line QCA of ≤48 mm.
• Percutaneous interventions for lesions in a non-target vessel are allowed if done ≥30 days prior to or if planned to be done 2 years after the index procedure.
• Percutaneous intervention for lesions in the target vessel are allowed if done >6 months prior to or if planned to be done 2 years after the index procedure.

Exclusion Criteria:

• Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and prasugrel and ticlopidine, inclusive), everolimus, poly (L-lactide), poly (DL-lactide), cobalt, chromium, nickel, tungsten, acrylic and fluoro polymers or contrast sensitivity that cannot be adequately pre-medicated.
• Subject has a known diagnosis of acute myocardial infarction (AMI) at any time preceding the index procedure and relevant cardiac enzymes (according to local standard hospital practice) have not returned within normal limits at the time of procedure.
• Evidence of ongoing acute myocardial infarction in ECG prior to procedure
• Subject has current unstable arrhythmias.
• Left ventricular ejection fraction (LVEF) < 30%.
• Subject has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant.
• Subject is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure.
• Subject is receiving immunosuppressant therapy and/or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus, rheumatoid arthritis, severe asthma requiring immunosuppressive medication, etc.).
• Subject is receiving chronic anticoagulation therapy that can not be stopped and restarted according to local hospital standard procedures.
• Elective surgery is planned within 2 years after the procedure that will require discontinuing either aspirin, clopidogrel, prasugrel or ticlopidine.
• Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3, a white blood cell count of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
• Known renal insufficiency (e.g., estimated glomerular filtration rate <60 ml/kg/1.73m² or serum creatinine level of >2.5 mg/dL, or subject on dialysis).
• History of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Subject has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past 6 months.
• Pregnant or nursing subjects and those who plan pregnancy in the period up to 3 years following index procedure. (Female subjects of child-bearing potential must have a negative pregnancy test done within 28 days prior to the index procedure and contraception must be used during participation in this trial)
• Other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
• Subject is already participating in another clinical investigation that has not yet reached its primary endpoint.
• Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff or sponsor staff) or subject unable to read or write.

Angiographic Exclusion Criteria

• Target lesion which prevents adequate (residual stenosis at target lesion(s) is ≤ 40% by visual assessment) coronary pre-dilatation.
• Target lesion in left main trunk.
• Aorto-ostial target lesion (within 3 mm of the aorta junction).
• Target lesion located within 2 mm of the origin of the LAD or LCX.
• Target lesion located distal to a diseased (vessel irregularity per angiogram and >20% stenosed lesion) arterial or saphenous vein graft.
• Target lesion involving a bifurcation lesion with side branch ≥2 mm in diameter, or with a side branch <2mm in diameter requiring guide wire protection or dilatation.
• Total occlusion (TIMI flow 0), prior to wire crossing
• Excessive tortuosity (≥ two 45° angles), or extreme angulation (≥90 °) proximal to or within the target lesion.
• Restenotic from previous intervention
• Heavy calcification proximal to or within the target lesion.
• Target lesion involves myocardial bridge.
• Target vessel contains thrombus as indicated in the angiographic images.
• Additionally clinically significant lesion(s) (≥ 40% diameter stenosis by visual assessment) for which percutaneous coronary intervention may be required <2 years after the index procedure.
• Subject has received brachytherapy in any epicardial vessel (including side branches)
• Subject has a high probability that a procedure other than pre-dilatation and study device implantation and (if necessary) post-dilatation will be required at the time of index procedure for treatment of the target vessel (e.g. atherectomy, cutting balloon)