NCT01605851已完成不适用
GORE® Septal Occluder EU Clinical Evaluation: A Study to Evaluate Clinical Success and Performance in the Treatment of Transcatheter Closure of Patent Foramen Ovale (PFO)
W.L.Gore & Associates9 个研究点 分布在 5 个国家目标入组 150 人开始时间: 2012年5月1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
- 150
- 试验地点
- 9
- 主要终点
- To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO
研究概览
简要总结
The primary objective of this study is to evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of Patent Foramen Ovale (PFO).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subjects with a PFO less than or equal to 17mm
排除标准
- 未提供
结局指标
主要结局
To evaluate clinical success and performance of the GORE® Septal Occluder when used for percutaneous, transcatheter closure of PFO
时间窗: 6 months
The primary endpoint for the study is composite Clinical Success evaluated at 6 months post-index procedure
次要结局
- Additional Clinical Success evaluated during the procedure and 6 months post-procedure(6 months)
研究者
研究点 (9)
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