Clinical Protocol Presillion™ and Presillion™ Plus Stent Systems
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Medinol Ltd.
- 入组人数
- 278
- 试验地点
- 30
- 主要终点
- Target vessel failure (TVF)
研究概览
简要总结
The purpose of this study is to collect and analyze additional information about the safety and effectiveness of the Presillion™ Stent System in the treatment of de novo stenotic lesions in native coronary arteries.
详细描述
This is a post market, non-randomized, multi-center, prospective, single arm clinical study that will be conducted at up to 25 sites in Europe and Israel. All patients will be followed at 30 days, 6 months, 9 months and 1 year post index stenting procedure.
The primary endpoint will be the incidence of target vessel failure (TVF, see definition below) within 270 days of treatment with the Presillion™ Stent System. This rate will be compared with a performance goal derived using a meta-analysis of the standard-of-care therapy, coronary stenting with bare metal stents. This data will be used to support the PMA application for the Presillion™ Stent System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 >= 18 years old.
- •Eligible for Percutaneous Coronary Intervention (PCI).
- •Patient understands the nature of the procedure and provides written informed consent prior to the catheterization procedure.
- •Patient is willing to comply with specified follow-up evaluation and can be contacted by telephone.
- •Acceptable candidate for coronary artery bypass graft (CABG) surgery.
- •Stable angina pectoris (Canadian Cardiovascular Society (CCS) 1, 2, 3 or 4) or unstable angina pectoris (Braunwald Class 1-3, B-C) or a positive functional ischemia study (e.g., ETT, SPECT, Stress echocardiography or Cardiac CT).
- •Male or non-pregnant female patient (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).
排除标准
- •Currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- •Previously enrolled in another stent trial in the previous 2 years.
- •ANY planned elective surgery or percutaneous intervention within subsequent 9 months.
- •A previous coronary interventional procedure of any kind within the 30 days prior to the procedure.
- •The subject requires staged procedure of either the target or any non-target vessel within 9 months post-procedure.
- •Previous drug eluting stent (DES) deployment anywhere in the target vessel.
- •Any drug eluting stent (DES) deployment anywhere within the past 12 months
- •Co-morbid condition(s) that could limit the patient's ability to participate in the trial or to comply with follow-up requirements, or impact the scientific integrity of the trial.
- •Concurrent medical condition with a life expectancy of less than 12 months.
- •Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity to contrast media, which cannot be adequately pre-medicated.
研究组 & 干预措施
Presillion™ Stent System
干预措施: Catheterization, stent deployment (Device)
结局指标
主要结局
Target vessel failure (TVF)
时间窗: 270 days
次要结局
未报告次要终点