NCT00752128已完成不适用
RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population
Medtronic Vascular1 个研究点 分布在 1 个国家目标入组 2,349 人开始时间: 2008年8月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,349
- 试验地点
- 1
- 主要终点
- Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)
研究概览
简要总结
The primary objective of the RESOLUTE international registry is to document the safety and overall clinical performance of the Resolute Zotarolimus-Eluting Coronary Stent System in a 'real-world' patient population requiring stent implantation.
详细描述
As part of the broader clinical program of the Resolute stent, the RESOLUTE International registry will expand the experience and understanding of the device performance in a 'real-world' setting. The registry intends to enroll patients from a large number of centers under commercial usage conditions, with the aim to reflect 'real-world' usage as much as possible.
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
- •Minimum legal age (18)
- •Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines
- •Patient has consented to participate and authorized in writing the collection and release of medical information
- •Elective use of the Endeavor Resolute stent
排除标准
- •Pregnancy
- •High probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons)
- •Currently participating in another trial preventing routine hospital treatment
- •Previous enrollment in the RESOLUTE International registry
结局指标
主要结局
Composite Endpoint of Cardiac Death and Myocardial Infarction (Not Clearly Attributable to a Non-target Vessel)
时间窗: 12 Months
次要结局
- Overall Stent Thrombosis, Defined as Definite and Probable Stent Thrombosis, According to the Academic Research Consortium (ARC) Definition(12 Months)
研究者
研究点 (1)
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