Researching AXIUM Coiling Experience and Recanalization (RACER)
NCT ID: NCT00703794
Last Updated: 2018-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
119 participants
OBSERVATIONAL
2008-06-30
2012-01-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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AXIUM Coils
The AXIUM Progressive Coil System
Embolization of aneurysm
Interventions
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The AXIUM Progressive Coil System
Embolization of aneurysm
Eligibility Criteria
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Inclusion Criteria
* Must be at least 18 years of age
* Aneurysm location, angio-architecture, morphology, or medical condition, is considered by the neurosurgical / interventional team to be at very high risk for management by traditional operative techniques, or aneurysm is considered to be inoperable
* Patient is willing to conduct follow-up visits
Exclusion Criteria
* Patient has a cerebral aneurysm with a location, angioarchitecture or morphology that presents an unacceptable risk of morbidity due to the Study procedures
* Patient is participating in another clinical research Study
* Patient has a medical, social or psychological condition, which precludes the patient from receiving Study required treatment, evaluation, procedures and follow-up
* Female patient is pregnant or breast-feeding
18 Years
ALL
No
Sponsors
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Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Principal Investigators
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Ajay K Wakhloo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Massachusetts, Worcester
Locations
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Kaleida Health - Millard Fillmore
Buffalo, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Lac+Usc/Uscuh
Los Angeles, California, United States
Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange
Orange, California, United States
Lee Memorial Health System
Fort Myers, Florida, United States
University of Miami - Jackson Memorial Hospital Systems
Miami, Florida, United States
Bayfront Medical Center
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Neurologic & Orthopedic Hospital of Chicago (NOHC)
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Massachusetts Medical Center
Worcester, Massachusetts, United States
Abbott Northwestern
Minneapolis, Minnesota, United States
Oregon Health & Science University (OHSU)
Portland, Oregon, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Palmetto Richland Health Memorial Hospital
Columbia, South Carolina, United States
Fletcher Allen Health Care
Burlington, Vermont, United States
University of Wisconsin
Madison, Wisconsin, United States
Countries
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References
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Casasco AE, Aymard A, Gobin YP, Houdart E, Rogopoulos A, George B, Hodes JE, Cophignon J, Merland JJ. Selective endovascular treatment of 71 intracranial aneurysms with platinum coils. J Neurosurg. 1993 Jul;79(1):3-10. doi: 10.3171/jns.1993.79.1.0003.
Wakhloo AK, Gounis MJ, Sandhu JS, Akkawi N, Schenck AE, Linfante I. Complex-shaped platinum coils for brain aneurysms: higher packing density, improved biomechanical stability, and midterm angiographic outcome. AJNR Am J Neuroradiol. 2007 Aug;28(7):1395-400. doi: 10.3174/ajnr.A0542.
Linfante I, Wakhloo AK. Brain aneurysms and arteriovenous malformations: advancements and emerging treatments in endovascular embolization. Stroke. 2007 Apr;38(4):1411-7. doi: 10.1161/01.STR.0000259824.10732.bb. Epub 2007 Feb 22.
Razack N, Thompson BG. Treatment of intracranial aneurysms: clipping or coiling? J Neuroophthalmol. 2004 Mar;24(1):1-2. doi: 10.1097/00041327-200403000-00001. No abstract available.
Mericle RA, Reig AS, Burry MV, Eskioglu E, Firment CS, Santra S. Endovascular surgery for proximal posterior inferior cerebellar artery aneurysms: an analysis of Glasgow Outcome Score by Hunt-Hess grades. Neurosurgery. 2006 Apr;58(4):619-25; discussion 619-25. doi: 10.1227/01.NEU.0000204127.81249.28.
Thornton J, Debrun GM, Aletich VA, Bashir Q, Charbel FT, Ausman J. Follow-up angiography of intracranial aneurysms treated with endovascular placement of Guglielmi detachable coils. Neurosurgery. 2002 Feb;50(2):239-49; discussion 249-50. doi: 10.1097/00006123-200202000-00003.
Related Links
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ev3 Inc.
Other Identifiers
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ev3-FD1942-CR00045
Identifier Type: -
Identifier Source: org_study_id
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