NCT02480348已完成不适用
Medtronic Polymer-Free Drug-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions
Medtronic Vascular24 个研究点 分布在 3 个国家目标入组 109 人开始时间: 2015年12月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 24
- 主要终点
- Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
研究概览
简要总结
The purpose of this trial is to evaluate the clinical safety and efficacy of the Polymer-Free Drug-Eluting coronary stent system for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter (RVD) that allows use of stents between 2.25 and 3.50 mm in diameter.
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
- •Must be an acceptable candidate for percutaneous coronary intervention, stenting, & emergent coronary artery bypass graft (CABG) surgery
- •Must have evidence of ischemic heart disease
- •Must require treatment of either a) a single target lesion amenable to treatment with a 2.25 mm - 3.50 mm stent OR b) two target lesions located in separate target vessels, with at least one of the target lesions amenable to treatment with a 2.25 mm - 3.50 mm mm study stent
- •Target lesion(s) must be de novo lesion(s) in native coronary artery(ies)
排除标准
- •Known hypersensitivity or contraindication to aspirin, heparin and bivalirudin, thienopyridines, cobalt, nickel, platinum, iridium, chromium, molybdenum, polymer coatings (e.g. BioLinx) or a sensitivity to contrast media, which cannot be adequately pre-medicated
- •History of an allergic reaction or significant sensitivity to drugs such as zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
- •History of a stroke or transient ischemic attack (TIA) within the prior 6 months
- •Active peptic ulcer or upper gastrointestinal (GI) bleeding within the prior 6 months
- •History of bleeding diathesis or coagulopathy or will refuse blood transfusions
- •Concurrent medical condition with a life expectancy of less than 5 years
- •Currently participating in an investigational drug or another device trial that has not completed the primary endpoint
- •Documented left ventricular ejection fraction (LVEF) < 30% at the most recent evaluation
结局指标
主要结局
Late lumen loss (LLL, in-stent) at 9 months post-procedure as measured by quantitative coronary angiography.
时间窗: 9 months
次要结局
未报告次要终点
研究者
研究点 (24)
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