NCT03063749已完成不适用
A Post-approval Study of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
Medtronic Vascular28 个研究点 分布在 4 个国家目标入组 416 人开始时间: 2017年3月30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
- 416
- 试验地点
- 28
- 主要终点
- Target Lesion Failure
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Target Lesion Failure
时间窗: 12 months
Target Lesion Failure (TLF), defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
次要结局
- Acute Success (Device, Lesion, Procedure)(30 days and 6, 12, 24, and 36 months post-procedure)
- Target Vessel Myocardial Infarction (TVMI)(30 days and 6, 12, 24, and 36 months post-procedure)
- Target Lesion Revascularization (TLR)(30 days and 6, 12, 24, and 36 months post-procedure)
- Cardiac Death and TVMI(30 days and 6, 12, 24, and 36 months post-procedure)
- Major Adverse Cardiac Event (MACE)(30 days and 6, 12, 24, and 36 months post-procedure)
- Target Vessel Revascularization (TVR)(30 days and 6, 12, 24, and 36 months post-procedure)
- Target Lesion Failure (TLF)(30 days and 6, 12, 24, and 36 months post-procedure)
- Cardiac Death(30 days and 6, 12, 24, and 36 months post-procedure)
- Target Vessel Failure (TVF)(30 days and 6, 12, 24, and 36 months post-procedure)
- Stent Thrombosis (ST)(30 days and 6, 12, 24, and 36 months post-procedure)
研究者
研究点 (28)
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