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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01465841
First received: October 28, 2011
Last updated: April 30, 2015
Last verified: April 2015
  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: September 2015
Estimated Primary Completion Date: June 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465841

Locations
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.
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: April 30, 2015
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
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Arterial Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2015