NCT01754051已完成不适用
VOLCAN: A Volumetric Coiling in Aneurysm Registry of the Penumbra Coil 400TM System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time of fluoroscopic exposure
研究概览
简要总结
This study is a prospective, multi-center registry of patients with intracranial aneurysms who are treated by the PC 400 System. Data for each patient are collected up to 12 ± 3 months post-procedure for the study.
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
- •Patients older than 18 years
- •Intracranial aneurysms >2mm, ruptured or unruptured
排除标准
- •Fusiform aneurysms
- •Dissecting aneurysms
- •Aneurysms associated with brain AVMs
- •Multiple aneurysms
- •Re-treated aneurysms
- •Patients in whom endovascular embolization therapies other than PC 400 System are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.
结局指标
主要结局
Time of fluoroscopic exposure
时间窗: During the procedure
Packing density with the number of coils implanted
时间窗: During the procedure
Quality of aneurysm occlusion post-operatively and at 12±3 months post-procedure based on the Raymond Scale
时间窗: At 1 year post-procedure
Procedural device-related serious adverse events at immediate post-procedure
时间窗: During the procedure
次要结局
- Adverse events occurring during the procedure and in the 30±7 days following the treatment.(During and at 30 days post-procedure)
- Acute occlusion of the aneurysm sac at immediate post-procedure(At immediate post-procedure)
研究者
研究点 (1)
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