Post Marketing Surveillance (PMS) Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure
研究概览
简要总结
The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).
详细描述
WIRION system is used as protection device in patients undergoing SVG stenting procedure. This retrospective study collects data on the usability of the WIRION during the procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Patients underwent percutaneous intervention (PI) of SVG stenting in which the WIRIONTM system was used.
- •Patient is greater than or equal to 18 years of age.
排除标准
- •Undergone cardiac surgery in the past 60 days before the procedure.
结局指标
主要结局
Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure
时间窗: 30 Days
Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.
Number of Patients That Undergo Successful SVG Procedure
时间窗: 30 Days
Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.
次要结局
未报告次要终点