This trial is active, not recruiting.

Conditions intracranial aneurysms, peripheral aneurysms
Treatment pc 400 coils (penumbra )
Phase phase 4
Sponsor Penumbra Inc.
Start date November 2011
End date June 2017
Trial size 2000 participants
Trial identifier NCT01465841, CLP 4492


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
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.

Primary Outcomes

Packing density with the number of coils implanted
time frame: At immediate post-procedure
Time of fluoroscopic exposure
time frame: At immediate post-procedure
Procedural device-related serious adverse events
time frame: At immediate post-procedure

Secondary Outcomes

Acute occlusion of the aneurysm sac
time frame: At immediate post-procedure
Intracranial hemorrhage
time frame: At discharge or 3 days post-procedure

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Penumbra Inc..