NCT02419521已完成不适用
A Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting Stent System Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
Medtronic Vascular24 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2015年7月7日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 24
- 主要终点
- In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
研究概览
简要总结
The purpose of this trial is to assess the safety and efficacy of the Resolute Onyx Zotarolimus-Eluting Coronary Stent System for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter of 2.25 mm to 4.2 mm.
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 (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
- •Must have clinical evidence of ischemic heart disease, stable or unstable angina, and/or a positive functional study
- •Must require treatment of either a) a single target lesion amenable to treatment OR b) two target lesions located in separate target vessels
- •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 12 months
- •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
研究组 & 干预措施
Device
Other
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
干预措施: Resolute Onyx Stent - 2.25 mm - 4.0 mm (Device)
结局指标
主要结局
In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
时间窗: 8 Months
In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography
次要结局
- Cardiac Death(8 Months)
- Target Vessel Myocardial Infarction (TVMI)(8 Months)
- Target Lesion Revascularization (TLR)(8 Months)
- Cardiac Death and TVMI(8 Months)
- Major Adverse Cardiac Event (MACE)(8 Months)
- Target Lesion Failure (TLF)(8 Months)
- Target Vessel Failure (TVF)(8 Months)
- Stent Thrombosis (ST)(8 Months)
研究者
研究点 (24)
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