A Post-Market Registry for the Evaluation of the CorPath 200 System Effectiveness in Percutaneous Coronary Interventions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 754
- 试验地点
- 16
- 主要终点
- Number of Participants With Clinical Success
研究概览
简要总结
To collect data on the routine patterns of use, safety and effectiveness, including the clinical and technical performance of the CorPath 200 System, in the delivery and manipulation of coronary guidewires and stent/balloon catheters during PCI procedures.
详细描述
This is a prospective, single-arm, open-label, multi-center patient registry of the CorPath 200 System to examine its performance during PCI procedure and patient outcomes through 72 hours post-procedure or hospital discharge, whichever occurs first.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Age >18 years.
- •Patients with coronary artery disease undergoing Percutaneous Coronary Intervention (PCI) with the CorPath 200 system.
- •The subject or the legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
排除标准
- •Concurrent enrollment in another device or drug study protocol that specifically excludes concurrent enrollment or that prevents collection of data required in this registry (concurrent participation in another registry is not an automatic exclusion criterion for this study).
- •Failure/inability/unwillingness to provide informed consent.
结局指标
主要结局
Number of Participants With Clinical Success
时间窗: In-hospital (72-hours or discharge, whichever occurs first)
Less than 30% residual stenosis post PCI in the lesion(s) treated with the CorPath system, without in-hospital major adverse coronary events (MACE).
次要结局
- Number of Participants With In-hospital Major Adverse Coronary Events (MACE)(In-hospital (72-hours or discharge, whichever occurs first))
- Number of Participants With an Adverse Event(In-hospital (72-hours or discharge, whichever occurs first))