ReferenceRRK4697

ACE

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

Research Summary

This study is a prospective multi-center study of patients with intracranial aneurysms peripheral aneurysms or other malformations who are treated by the PC 400 System. Data for each patient are collected up to 6 months post-procedure for the study. It may also be collected up to one year in accordance to the standard of care at each hospital at the discretion of the investigators.Approximately 2000 patients with intracranial aneurysms peripheral aneurysms or other malformations treated by the PC 400 System at up to 100 centers will be enrolled. Each center must have had prior experience with endovascular embolization by the PC 400 System before being able to enroll patients. This is defined as having treated at least 5 patients according to the cleared indication for use either before or after IRB/EC approval (roll-in). Roll-in patients will not be part of the study.

Research Overview
PI Name Thomas - A
Speciality
Sponsor Penumbra Inc.
Project Status Open
Proposed End Date 17/04/2014
Study Run through CRF? No
Recruitment so far 0