A Prospective, Multi-center, Single Arm Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System When Used in Conjunction With Endovascular Coil Embolization in the Treatment of Wide-necked Saccular Intracranial Aneurysms
Status: Terminated
Location: See all (11) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
View:
• Target aneurysm is an unruptured wide-neck, intracranial, saccular anterior circulation aneurysm (≤ 10 mm) arising from a parent vessel with a diameter of ≥ 2.5 mm and ≤ 4 mm
• Subject understands the nature of the procedure and provides voluntary written informed consent prior to the treatment
• Subject is willing to comply with specified follow-up evaluation
Locations
United States
Colorado
Radiology Imaging Associates
Englewood
Florida
University of Florida
Gainesville
Lyerly Neurosurgery, an Affiliate of Baptist Health
Jacksonville
Illinois
University of Illinois at Chicago
Chicago
Massachusetts
University of Massachusetts Medical Center
Worcester
Maryland
Johns Hopkins University
Baltimore
New York
University of Buffalo
Buffalo
Mount Sinai Health System
New York
Ohio
Miami Valley Hospital
Dayton
Pennsylvania
Lehigh Valley Health Network
Allentown
Virginia
Inova Fairfax Hospital
Falls Church
Time Frame
Start Date: 2015-09-01
Completion Date: 2019-09-21
Participants
Target number of participants: 45
Treatments
Experimental: Enterprise
Authors
Related Therapeutic Areas
Sponsors
Leads: Cerenovus, Part of DePuy Synthes Products, Inc.