first-in-man trial examining the safety and efficacy of buma supreme and resolute integrity in patients with de novo coronary artery stenosis

Conditions: Coronary Artery Disease

Summary: prospective, multi-center, randomized 1:1, single blind trial using buma supreme versus resolute integrity conducted in approximately 14 interventional cardiology centers in the netherlands, belgium, spain and portugal. clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. all patients will undergo repeat angiography at 9 months follow-up. qca assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.


Eligibility criteria:
inclusion criteria: 1. the subject is at least 18 years of age. 2. clinical evidence of ischemic heart disease and/or a positive territorial functional study. 3. documented stable angina pectoris (canadian cardiovascular society (ccs) classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (braunwald class ib-c, iib-c, or iiib-c), or documented silent ischemia 4. the patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (lad, lcx or rca). 5. diameter stenosis≥50 and\<100%. 6. the visually estimated target lesion must be able to be covered by a single buma supreme stent or a single resolute integrity stent (for available sizes refer to tables 1 and 2, page 20 and 21). 7. the target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter. 8. written informed consent. 9. the patient agrees to the follow-up visits including a 9 month angiographic follow-up. 10. patient must have completed the follow-up phase of any previous study. exclusion criteria: 1. female of child bearing potential (age \<50 years and last menstruation within the last 12 months). subjects with age \<50 who underwent tubal ligation, ovariectomy or hysterectomy can be included. 2. evidence of ongoing acute myocardial infarction (ami) in ecg and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure 3. patient suffered from stroke/tia during the last 6 months. 4. lvef \<30% 5. platelet count \ 400,000 cells/mm3, a wbc of \<3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis) 6. known renal insufficiency (e.g. serum creatinine \>2.5mg/dl, or creatinine clearance ≤30 ml/min), or subject on dialysis, or acute kidney failure (as per physician judgment). 7. patient undergoing planned surgery within 6 months with the necessity to stop dapt. 8. patient requiring oral anticoagulation (coumadin, novel oral anticoagulant (noac)) 9. history of bleeding diathesis or coagulopathy 10. the patient is a recipient of a heart transplant 11. known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium. 12. other medical illness (e.g. cancer, stroke with neurological deficiency) 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 13. the patient is simultaneously participating in another investigational device or drug study