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Sponsored by: |
ev3 Endovascular, Inc. |
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Information provided by: | ev3 Endovascular, Inc. |
ClinicalTrials.gov Identifier: | NCT00703794 |
The data collected in this study will be used to support International Regulatory submissions. The study objective is to evaluate the continued safety and efficacy of the AXIUM Progressive Coil System.
This Device has been used clinically at approximately 150 Institutions under FDA 510(k) clearance since April 24, 2007. The device received CE authorization on June 30, 2007. Through December 2007, more than 1000 patients have been treated with the AXIUM Coils.
Condition | Intervention | Phase |
---|---|---|
Aneurysms Vascular Diseases Cerebrovascular Disorders Intracranial Arterial Diseases |
Device: The AXIUM Progressive Coil System |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | ev3 Researching AXIUM Coiling Experience and Recanalization (RACER) |
Estimated Enrollment: | 125 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
AXIUM Coils: Experimental |
Device: The AXIUM Progressive Coil System
Embolization of aneurysm
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathy Akagha, MPH | 949-837-3700 | kakagha@ev3.net |
United States, California | |
Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange | Recruiting |
Orange, California, United States, 92868 | |
Contact: Doreen Robinson, RN, CCRC 714-560-4450 | |
Principal Investigator: Howard L. Dorne, MD | |
United States, Florida | |
Lee Memorial Health System | Recruiting |
Fort Myers, Florida, United States, 33908 | |
Contact: Katie Knutson 239-336-6800 | |
Principal Investigator: Eric Eskioglu, MD | |
Bayfront Medical Center | Recruiting |
Saint Petersburg, Florida, United States, 33701 | |
Contact: Andrea Bozeman 727-893-6040 | |
Principal Investigator: Nasser Razack, MD | |
United States, Illinois | |
Neurologic & Orthopedic Hospital of Chicago (NOHC) | Recruiting |
Chicago, Illinois, United States, 60640 | |
Contact: Grant Griffin 773-250-0423 | |
Principal Investigator: Demetrius Lopes, MD | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Colin Gorman 617-726-9143 | |
Principal Investigator: Albert Yoo, MD | |
University of Massachusetts Medical Center | Recruiting |
Worcester, Massachusetts, United States, 01655 | |
Contact: Jill Gray 508-856-6941 | |
United States, New York | |
Kaleida Health - Millard Fillmore | Recruiting |
Buffalo, New York, United States, 14209 | |
Contact: Annemarie Crumlish 716-887-5200 | |
Principal Investigator: Elad Levy, MD | |
United States, Ohio | |
Cleveland Clinic Foundation | Recruiting |
Cleveland, Ohio, United States, 44195 | |
Contact: Doreen Andrews-Hinders 216-445-9243 | |
Principal Investigator: Peter Rasmussen, MD | |
United States, South Carolina | |
Medical University of South Carolina (MUSC) | Recruiting |
Charleston, South Carolina, United States, 29425 | |
Contact: Adrian T Parker 843-792-3164 | |
Principal Investigator: Aquilla S Turk, DO | |
United States, Vermont | |
Fletcher Allen Health Care | Recruiting |
Burlington, Vermont, United States, 05401-1473 | |
Contact: Hollister McFadden 802-847-6845 | |
Principal Investigator: Grant Linnell, DO |
Principal Investigator: | Ajay K Wakhloo, MD, PhD | University of Massachusetts |
Responsible Party: | ev3 Neurovascular Clinical Research Manager ( ev3 Neurovascular ) |
Study ID Numbers: | ev3-FD1942-CR00045 |
Study First Received: | June 23, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00703794 |
Health Authority: | United States: Institutional Review Board |
ev3 Neurovascular aneurysms cerebrovascular endovascular neurovascular therapies RACER AXIUM |
The AXIUM Progressive Coil System ev3 MTI Micro Therapeutics FX detachable coil system K060747 brain diseases |
Aneurysm Vascular Diseases Central Nervous System Diseases |
Brain Diseases Intracranial Arterial Diseases Cerebrovascular Disorders |
Nervous System Diseases Cardiovascular Diseases |