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Clinical Trial Details

NCT ID: NCT01465841
Date Last Changed: November 6, 2014

Overview

Research Study Summary

A clinical trial to evaluate treatments using PC 400 coils (Penumbra ) for patients with Intracranial Aneurysms or Peripheral Aneurysms

Research Study Title

ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System

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.

To Learn more

Recruitment Details

Phase
4
Gender
Both Male and Female
Age
N/A
Overall Status
Recruiting
Lead Sponsor
Penumbra Inc.
Duration
43 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages up to N/A

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.

Site Locations (6)

Country State City Zip Facility and Contact
United States California Newport Beach 92658-6100 Hoag Hospital
Laura Whitake, RN
949-764-8190
laura.whitaker@hoaghospital.org

Michael Brant-Zawadzki, MD
Principal Investigator
United States Illinois Chicago 60612-3833 Rush University Medical Center
Demetrius Lopes, MD
312-942-6644
dlopes@neurosource.com

Demetrius Lopes, MD
Principal Investigator
United States New York New York NY 10029 Mount Sinai School of Medicine
Maritsa Polykarpou
212-241-3457
Maritsa.polykarpou@mssm.edu

Aman Patel, MD
Principal Investigator
United States New York Syracuse 13210 State University of New York Upstate Medical Center
Mark Villwock
216-235-8727
villwocm@upstate.edu

Eric Deshaies, MD
Principal Investigator
United States Tennessee Knoxville 37916 Fort Sanders Medical Center
Carla Staruk
865-541-2925
cjackso3@covhlth.com

Keith Woodward, MD
Principal Investigator
United States Texas Houston 77030 The Methodist Hospital Research Institute
Marilyn Bautista
713-441-1409
mhbautista@tmhs.org

Richard Klucznik, MD
Principal Investigator

Contact

Emily Luong, B.A.
510-748-3138
E-mail:

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