Trial record 1 of 1 for:    nct01465841
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Study of the Penumbra Coil 400 System to Treat Aneurysm (ACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Penumbra Inc.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01465841
First received: October 28, 2011
Last updated: February 4, 2014
Last verified: February 2014

October 28, 2011
February 4, 2014
November 2011
October 2015   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01465841 on ClinicalTrials.gov Archive Site
  • 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 ]
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
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
April 2016
October 2015   (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.
Both
Not Provided
No
Contact: Emily Luong, B.A. 510-748-3138 eluong@penumbrainc.com
Contact: Siu P Sit, PhD 510 748 3221 siupo.sit@penumbrainc.com
United States
 
NCT01465841
CLP 4492, CLP 4492
No
Penumbra Inc.
Penumbra Inc.
Not Provided
Study Director: Siu P Sit, PhD Penumbra Inc.
Penumbra Inc.
February 2014

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