NCT03584464已完成不适用
A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Vascular48 个研究点 分布在 4 个国家目标入组 205 人开始时间: 2018年5月14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
- 205
- 试验地点
- 48
- 主要终点
- Number of Participants With Target Vessel Failure (TVF)
研究概览
简要总结
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.
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
- •Symptomatic coronary artery disease including subjects with chronic stable angina, silent ischemia, and acute coronary syndromes including non-ST elevation and ST-elevation myocardial infarction
- •Subject is an acceptable candidate for treatment with a drug eluting stent in accordance with the applicable guidelines on percutaneous coronary interventions, manufacturer's Instructions for Use, and the Declaration of Helsinki
- •Subject requires treatment of a single de novo bifurcated lesion amenable to treatment with Resolute Onyx using the provisional stenting technique
排除标准
- •Unprotected left main disease
- •Subjects with planned PCI of three vessel disease
- •Planned two stent technique (main branch and side branch) of a bifurcation
- •Subjects with more than one bifurcation lesion
结局指标
主要结局
Number of Participants With Target Vessel Failure (TVF)
时间窗: 12 Months
Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
次要结局
- Number of Participants With Target Vessel Revascularization (TVR)(12 months)
- Number of Participants With Cardiac Death(12 months)
- Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)(Up to 12 months)
- Number of Participants With Target Lesion Revascularization (TLR)(12 months)
- Number of Participants With Target Lesion Failure (TLF)(12 months)
- Number of Participants With Cardiac Death and TVMI(12 months)
- Number of Participants With Major Adverse Cardiac Event (MACE)(12 months)
- Number of Participants With Stent Thrombosis (ARC) Definite/Probable(12 months)
研究者
研究点 (48)
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