Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE)
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.
Device: PC 400 coils (Penumbra )
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System|
- Packing density with the number of coils implanted [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: No ]The data will be captured at the end of the coiling procedure which is standard for aneurysm studies.
- Time of fluoroscopic exposure [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: Yes ]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 [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: Yes ]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.
- Acute occlusion of the aneurysm sac [ Time Frame: At immediate post-procedure ] [ Designated as safety issue: No ]
- Intracranial hemorrhage [ Time Frame: At discharge or 3 days post-procedure ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||September 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
|Experimental: Embolization with the PC 400 coils||
Device: PC 400 coils (Penumbra )
The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465841
|United States, California|
|Newport Beach, California, United States, 92658-6100|
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612-3833|
|United States, New York|
|Mount Sinai School of Medicine|
|New York, New York, United States, NY 10029|
|State University of New York Upstate Medical Center|
|Syracuse, New York, United States, 13210|
|United States, Tennessee|
|Fort Sanders Medical Center|
|Knoxville, Tennessee, United States, 37916|
|United States, Texas|
|The Methodist Hospital Research Institute|
|Houston, Texas, United States, 77030|
|Study Director:||Siu P Sit, PhD||Penumbra Inc.|