Vascular Diseases Clinical Trial
— RACEROfficial title:
ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)
Verified date | October 2018 |
Source | Medtronic Neurovascular Clinical Affairs |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 119 |
Est. completion date | January 16, 2012 |
Est. primary completion date | January 16, 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient or patient's legally authorized representative has signed and dated an Informed Consent Form - 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: - Aneurysm was previously treated - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | Kaleida Health - Millard Fillmore | Buffalo | New York |
United States | Fletcher Allen Health Care | Burlington | Vermont |
United States | Medical University of South Carolina (MUSC) | Charleston | South Carolina |
United States | Neurologic & Orthopedic Hospital of Chicago (NOHC) | Chicago | Illinois |
United States | Cleveland Clinic Foundation | Cleveland | Ohio |
United States | Palmetto Richland Health Memorial Hospital | Columbia | South Carolina |
United States | Lee Memorial Health System | Fort Myers | Florida |
United States | Lac+Usc/Uscuh | Los Angeles | California |
United States | University of Wisconsin | Madison | Wisconsin |
United States | University of Miami - Jackson Memorial Hospital Systems | Miami | Florida |
United States | Abbott Northwestern | Minneapolis | Minnesota |
United States | Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange | Orange | California |
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
United States | Oregon Health & Science University (OHSU) | Portland | Oregon |
United States | Bayfront Medical Center | Saint Petersburg | Florida |
United States | Tampa General Hospital | Tampa | Florida |
United States | University of Massachusetts Medical Center | Worcester | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Medtronic Neurovascular Clinical Affairs |
United States,
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. — View Citation
Linfante I, Wakhloo AK. Brain aneurysms and arteriovenous malformations: advancements and emerging treatments in endovascular embolization. Stroke. 2007 Apr;38(4):1411-7. Epub 2007 Feb 22. Review. — View Citation
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. — View Citation
Razack N, Thompson BG. Treatment of intracranial aneurysms: clipping or coiling? J Neuroophthalmol. 2004 Mar;24(1):1-2. — View Citation
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. Review. — View Citation
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. — View Citation
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---|---|---|---|---|
Primary | Percent Occlusion | Defined in protocol | ||
Secondary | Morbidity/Mortality | Defined in protocol |
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