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Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465841
Recruitment Status : Active, not recruiting
First Posted : November 7, 2011
Last Update Posted : September 28, 2016
Information provided by (Responsible Party):
Penumbra Inc.

October 28, 2011
November 7, 2011
September 28, 2016
November 2011
June 2017   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01465841 on Archive Site
  • Acute occlusion of the aneurysm sac [ Time Frame: At immediate post-procedure ]
  • Intracranial hemorrhage [ Time Frame: At discharge or 3 days post-procedure ]
Same as current
Not Provided
Not Provided
Study of the Penumbra Coil 400 System to Treat Aneurysm
ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
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.
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Intracranial Aneurysms
  • Peripheral Aneurysms
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.
Experimental: Embolization with the PC 400 coils
Intervention: Device: PC 400 coils (Penumbra )
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Active, not recruiting
Same as current
June 2017
June 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
Child, Adult, Older Adult
Contact information is only displayed when the study is recruiting subjects
United States
CLP 4492
CLP 4492 ( Other Identifier: Penumbra Inc )
Not Provided
Not Provided
Penumbra Inc.
Penumbra Inc.
Not Provided
Study Director: Siu P Sit, PhD Penumbra Inc.
Penumbra Inc.
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP