ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System

Penumbra Inc.6 个研究点分布在 1 个国家目标入组 517 人2011年11月

适应症Intracranial Aneurysms Peripheral Aneurysms

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Intracranial Aneurysms
发起方: Penumbra Inc.
入组人数: 517
试验地点: 6
主要终点: Packing Density With the Number of Coils Implanted
状态: 已完成
最后更新: 5年前

概览研究者入排标准结局指标研究点相似试验

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.

注册库

clinicaltrials.gov

开始日期

2011年11月

结束日期

2017年6月

最后更新

5年前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Penumbra Inc.

责任方

Sponsor

入排标准

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.