A Prospective Multicenter Post Market Trial to Assess the Safety and Effectiveness of the Firehawk™ Rapamycin Target Eluting Cobalt Chromium Coronary Stent System (Firehawk™ Stent System) for the Treatment of Atherosclerotic Lesion(s)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,653
- 试验地点
- 1
- 主要终点
- Target Lesion Failure
研究概览
简要总结
Purpose The TARGET All comers trial is a prospective, multicenter, randomized, two-arm, non-inferiority, open-label study with 1656 patients at 20 centers in Europe. The study is a "real world, all comers" study.
详细描述
Primary objective: to compare the MicroPort Medical (Group) Co., Ltd Firehawk™cobalt chromium coronary stent ( rapamycin target eluting ) system with abluminal grooves containing a biodegradable polymer with the Abbott XIENCE family EES (Everolimus-Eluting stent) system with respect to cardiac death, myocardial infarction (not clearly attributable to a non-target vessel), Target Lesion Revascularization at 1 year in a "real world" patient population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Minimal age 18 years
- •Symptomatic coronary artery disease
- •Patient acceptable candidate for treatment with drug eluting stent in accordance with applicable guidelines
- •Presence of one or more coronary artery stenosis >50% with reference diameter 2.25-4.0mm which can be covered by one or multiple stents
- •Patient indication, lesion length and vessel diameter according to 'Instructions for Use' of study stents
- •Patient is willing and able to cooperate with study procedures and required follow up visits and patient or legal representative has been informed and agrees by signing EC approved written informed consent
排除标准
- •Women of childbearing potential who do not have a negative pregnancy test within 7 days before procedure and women who are lactating
- •Known intolerance to aspirin, clopidogrel or ticlopidin, heparin, cobalt, nickel, chromium, molybdenum, polymer coatings, Sirolimus, Everolimus, or contrast material
- •Participating in other trial before reaching primary endpoint
- •Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period.
结局指标
主要结局
Target Lesion Failure
时间窗: 12 months
Percentage of participants that had either Cardiac Death, Myocardial Infarction (not clearly attributable to a non-target vessel)or Target Lesion Revascularization (TLR, clinically indicated) after one year
次要结局
- In-stent late loss(13 months)
- stent struth Neointimal thickness(3 months)