multicentric belgium/netherlands pro-kinetic safety and efficacy study

Conditions: Coronary Artery Disease

Summary: the primary objective of this study is to evaluate safety and efficacy of the biotronik pro-kinetic coronary cocr-stent in patients with single de novo lesions of native coronary arteries.

the pro-kinetic study is a multi-center, prospective, consecutive non-randomized study enrolling 200 patients with single de novo lesions in native coronary arteries meeting the entry criteria. those who provide informed consent will be enrolled to receive the pro-kinetic stent. telephone follow-up will be performed at 1 month for all enrolled patients. after 6 months 100 patients will have an angiographic follow-up and 100 patients will be checked by telephone again. additionally, a clinical telephone follow-up will be performed in all patients after 12 months. this study is designed to yield data on the clinical safety and efficacy of the pro-kinetic stent in the coronary artery application. the target vessel failure rate after 6 months shall be below 18 % (max. 35 serious adverse events and expedited events) to show a safety/performance profile that could be considered in the range of the currently available bare metal stent systems

Eligibility criteria:
inclusion criteria: * patient must be at least 18 years old. * eligible for percutaneous coronary intervention (pci). * documented stable (canadian cardiovascular society classification \[ccs\] 1, 2, 3, or 4) or unstable (braunwald type i, ii, iii and a, b or c) angina pectoris, or documented silent ischemia. * left ventricular ejection fraction (lvef) \> 30% documented within the last 6 weeks. * acceptable candidate for coronary artery bypass graft surgery (cabg). * patient understands the study requirements and the treatment procedures and provides written informed consent on a form that has been approved the by local institutional review board before any specific test of the study or procedure is performed. * willing to comply with all the specified follow-up evaluations. * single target vessels to be treated. * single target lesion to be treated. * target lesion must be completely coverable by one study stent. * total target lesion length \<20 mm based on a visual estimate. * rvd of ≥ 2.0 mm to ≤ 5.0 mm based on a visual estimate. * target lesion diameter stenosis ≥ 50% and \< 100% based on a visual estimate. * target lesion has not undergone prior revascularization up to now. * target vessel has not undergone prior revascularization within the preceding 6 months. * patient has no child bearing potential, is not pregnant, or intends to become pregnant during the study. exclusion criteria: * planned treatment with any other pci device in target vessel except the pre-dilatation balloon. * mi within 72 hours prior to the index procedure and/or creatine kinase (ck) \> 2 times the local laboratory upper limits of normal, measured on the day of the index procedure, associated with elevated mb. * the patient is in cardiogenic shock. * cerebrovascular accident (cva) within the past 6 months. * acute or chronic renal dysfunction (creatinine \> 2.0 mg/dl or \> 150 µmol/l). * contraindication to asa or to clopidogrel. * known thrombocytopenia (platelet count 100, 000/mm3). * active gastrointestinal (gi) bleeding within the past three months. * known allergy to stainless steel or cobalt chromium. * any prior true anaphylactic reaction to contrast agents. * patient is currently taking colchicine. * life expectancy of less than 24 months due to other medical conditions. * co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study. * currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study. * left main coronary artery disease (stenosis \> 50%), whether protected or unprotected. * target lesion site is ostial (within 3.0 mm of vessel origin). * target lesion and/or target vessel proximal to the target lesion is severely calcified by visual estimation. * target lesion involves a bifurcation that requires intervention (usually, side branch \>2 mm in diameter). * target lesion is totally occluded (100% stenosis usually associated with timi flow ≤1). * angiographic presence of probable or definite thrombus. * target vessel will be pre-treated with an unapproved device, directional or rotational coronary atherectomy, laser, cutting balloon or transluminal extraction catheter prior to stent placement. * prior coronary intervention using brachytherapy to any segment of the target vessel. * angiographic restenosis of any segment of the target vessel that has undergone prior percutaneous coronary intervention. * angiographic evidence of atherosclerotic disease with \> 50% diameter stenosis (by visual estimate) proximal or distal to the target lesion * prior surgical revascularization of the target vessel with a documented patent graft (either a saphenous vein or an arterial conduit).

Keywords: stents