angina pectoris ischemic heart disease
Conditions
Interventions
Patients randomised in the scaffold group are treated with a bioabsorbable
scaffold, the control group patients with a Xience stent. During the procedure
also IVUS and lipiscan (Erasmus) imaging wil
Sponsors
Abbott Vascular International BVBA
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 medications and invasive procedures. Questionnairebased 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 scaffold 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 ESC 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 (LAD with septal and diagonal branches, LCX with obtuse marginal and/or ramus intermedius branches and RCA and any of its branches). • Target lesion(s) must have a visually estimated diameter stenosis of >=50% and = 1. • Lesion(s) must be located in a native coronary artery with Dmax by online QCA of >= 2.25 mm and =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
Exclusion criteria: General Exclusion Criteria • Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medications 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) 700,000 cells/mm3, a WBC 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 les
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Vasomotion assessed by change in Mean Lumen Diameter between pre- and post-nitrate at 3 years (superiority) • Minimum Lumen Diameter (MLD) at 3 years post nitrate minus MLD post procedure post nitrate (non-inferiority, reflex to superiority) | — |
Secondary
| Measure | Time frame |
|---|---|
| -) Acute success, including stent success (lesion analysis) and procedural success (subject analysis) -) Clinical endpoints (after 30 days, 180 days, 1-5 years follow up), including: death (cardiac, vascular, not cardiovascular), myocardial infarction (MI: QMI and NQMI) , revascularization -) Composite endpoints, including: Death / MI all, Cardiac death -) Scaffold-/stenttrombose, incl timing (acute, subacute, late and very late) -) Quality of Life (QoL) | — |
Countries
Netherlands
Outcome results
None listed