Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE)
This study is currently recruiting participants.
Verified December 2012 by Penumbra Inc.
Sponsor:
Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01465841
First received: October 28, 2011
Last updated: December 10, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Intracranial Aneurysms Peripheral Aneurysms |
Device: PC 400 coils (Penumbra ) |
Phase 4 |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by Penumbra Inc.:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 2000 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01465841
Contacts
| Contact: Malia McPherson, B.A. | 510-748-3294 | malia.mcpherson@penumbrainc.com |
| Contact: Siu P Sit, PhD | 510 748 3221 | siupo.sit@penumbrainc.com |
Locations
| United States, California | |
| Hoag Hospital | Recruiting |
| Newport Beach, California, United States, 92658-6100 | |
| Contact: Laura Whitake, RN 949-764-8190 laura.whitaker@hoaghospital.org | |
| Contact: Michael Brant-Zawadzki, MD michael.brantzawadzki@hoaghospital.org | |
| Principal Investigator: Michael Brant-Zawadzki, MD | |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612-3833 | |
| Contact: Demetrius Lopes, MD 312-942-6644 dlopes@neurosource.com | |
| Principal Investigator: Demetrius Lopes, MD | |
| United States, New York | |
| State University of New York Upstate Medical Center | Recruiting |
| Syracuse, New York, United States, 13210 | |
| Contact: Mark Villwock 216-235-8727 villwocm@upstate.edu | |
| Principal Investigator: Eric Deshaies, MD | |
| United States, Tennessee | |
| Fort Sanders Medical Center | Recruiting |
| Knoxville, Tennessee, United States, 37916 | |
| Contact: Carla Staruk 865-541-2925 cjackso3@covhlth.com | |
| Principal Investigator: Keith Woodward, MD | |
| United States, Texas | |
| The Methodist Hospital Research Institute | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Marilyn Bautista 713-441-1409 mhbautista@tmhs.org | |
| Principal Investigator: Richard Klucznik, MD | |
Sponsors and Collaborators
Penumbra Inc.
Investigators
| Study Director: | Siu P Sit, PhD | Penumbra Inc. |
More Information
No publications provided
| Responsible Party: | Penumbra Inc. |
| ClinicalTrials.gov Identifier: | NCT01465841 History of Changes |
| Other Study ID Numbers: | CLP 4492, CLP 4492 |
| Study First Received: | October 28, 2011 |
| Last Updated: | December 10, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Penumbra Inc.:
|
intracranial aneurysms Peripheral aneurysms acute treatment PC 400 System packing density |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013