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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
The purpose of this study is to demonstrate effectiveness and safety of the CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System.
The study is a prospective, multi-center, single arm, clinical study to evaluate the safety and effectiveness of the ENTERPRISE stent when used in conjunction with endovascular coil embolization in the treatment of unruptured wide-neck, intracranial, saccular anterior circulation aneurysms (≤ 10 mm). The primary objectives of the study are to evaluate the rate of complete angiographic occlusion at 12 months.
Age
21 - 70 years
Sex
ALL
Healthy Volunteers
No
Radiology Imaging Associates
Englewood, Colorado, United States
University of Florida
Gainesville, Florida, United States
Lyerly Neurosurgery, an Affiliate of Baptist Health
Jacksonville, Florida, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
University of Buffalo
Buffalo, New York, United States
Mount Sinai Health System
New York, New York, United States
Miami Valley Hospital
Dayton, Ohio, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, United States
Start Date
September 1, 2015
Primary Completion Date
January 8, 2019
Completion Date
September 21, 2019
Last Updated
October 23, 2020
45
ACTUAL participants
CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System
DEVICE
Lead Sponsor
Cerenovus, Part of DePuy Synthes Products, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06174727