ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 517
- 试验地点
- 11
- 主要终点
- Packing Density With the Number of Coils Implanted
研究概览
简要总结
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.
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 PC 400 System which is for the endovascular embolization of:
- •Intracranial aneurysms
- •Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- •Arterial and venous embolizations in the peripheral vasculature
排除标准
- •Patients in whom endovascular embolization therapies other than Penumbra Coils 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
Packing Density With the Number of Coils Implanted
时间窗: At immediate post-procedure
The data will be captured at the end of the coiling procedure which is standard for aneurysm studies.
Time of Fluoroscopic Exposure
时间窗: At immediate post-procedure
The total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coiling procedure.
Procedural Device-related Serious Adverse Events
时间窗: At immediate post-procedure
Procedural on-the-table serious adverse events will be captured and recorded at the end of the procedure. The duration of the procedure can be variable, depending on the time to access the target lesion and the time to complete the coiling procedure.
次要结局
- Acute Occlusion of the Aneurysm Sac(At immediate post-procedure)
- Intracranial Hemorrhage(At discharge or 3 days post-procedure)