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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 : Completed
First Posted : November 6, 2011
Results First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Information provided by (Responsible Party):
Penumbra Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Intracranial Aneurysms Peripheral Aneurysms Device: PC 400 coils (Penumbra ) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 517 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Secondary Outcome Measures :
  1. 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.

  2. Intracranial Hemorrhage [ Time Frame: At discharge or 3 days post-procedure ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01465841

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United States, California
Hoag Hospital
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
Sponsors and Collaborators
Penumbra Inc.
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Study Director: Siu P Sit, PhD Penumbra Inc.
  Study Documents (Full-Text)

Documents provided by Penumbra Inc.:
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Responsible Party: Penumbra Inc. Identifier: NCT01465841    
Other Study ID Numbers: CLP 4492
CLP 4492 ( Other Identifier: Penumbra Inc )
First Posted: November 6, 2011    Key Record Dates
Results First Posted: July 7, 2020
Last Update Posted: July 7, 2020
Last Verified: June 2020
Keywords provided by Penumbra Inc.:
intracranial aneurysms
Peripheral aneurysms
acute treatment
PC 400 System
packing density
Additional relevant MeSH terms:
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Intracranial Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases