CLP 7463: Visceral Artery Aneurysm Embolization by the Penumbra Ruby™ Coil System
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 1. Packing density with the number of coils implanted
研究概览
简要总结
The primary objective of this study is to gather post market data on the Penumbra Ruby Coil System in the treatment of visceral artery aneurysms and arteriovenous malformations. This study is a prospective, multi-center study of patients with visceral artery aneurysms and visceral arteriovenous malformations who are treated by the Penumbra Ruby Coil System. Data for each patient are collected up to 12 months post-procedure for the study.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in this study must be those treated according to the cleared indication for the Penumbra Ruby Coil System for visceral arterial and venous embolizations.
排除标准
- •Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study.
研究组 & 干预措施
Penumbra Ruby Coil System
干预措施: Penumbra Ruby Coil System (Device)
结局指标
主要结局
1. Packing density with the number of coils implanted
时间窗: During the procedure
2. Time of fluoroscopic exposure
时间窗: During the procedure
3. Procedural device-related serious adverse events at immediate post-procedure
时间窗: At immediate post-procedure
4. Occlusion of the aneurysm sac or target vessel at immediate post-procedure
时间窗: At immediate post-procedure
5. Occlusion of the aneurysm sac or target vessel at one year post-procedure
时间窗: One year post-procedure
次要结局
- 1. Recanalization of the aneurysm sac or target vessel at 4 months post-procedure(4 months post-procedure)