6 Months Evaluation of the BIOTRONIK PRO-Kinetic Coronary Stent System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biotronik AG
- 入组人数
- 202
- 主要终点
- Target Vessel Failure (TVF)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Target Vessel Failure (TVF)
时间窗: at 180 days post procedure
Target vessel failure is defined as composite of revascularization, recurrent myocardial infarction, or cardiac death.
次要结局
- Major Adverse Cardiac Events (MACE)(at 180 days post procedure)