Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE)
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|ClinicalTrials.gov Identifier: NCT01465841|
Recruitment Status : Completed
First Posted : November 6, 2011
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Intracranial Aneurysms Peripheral Aneurysms||Device: PC 400 coils (Penumbra )||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||517 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
|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.
- Packing Density With the Number of Coils Implanted [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Acute Occlusion of the Aneurysm Sac [ Time Frame: At immediate post-procedure ]Measured using Raymond Roy classification where grading ranges from I to III and higher values represent a worse outcome.
- Intracranial Hemorrhage [ Time Frame: At discharge or 3 days post-procedure ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.|