Researching AXIUM Coiling Experience and Recanalization (RACER)
Overview
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.
Full Title of Study: “ev3 Researching AXIUM Coiling Experience and Recanalization (RACER)”
Study Type
- Study Type: Observational [Patient Registry]
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: January 16, 2012
Interventions
- Device: The AXIUM Progressive Coil System
- Embolization of aneurysm
Arms, Groups and Cohorts
- AXIUM Coils
Clinical Trial Outcome Measures
Primary Measures
- Percent Occlusion
- Time Frame: Defined in protocol
Secondary Measures
- Morbidity/Mortality
- Time Frame: Defined in protocol
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Ajay K Wakhloo, MD, PhD, Principal Investigator, University of Massachusetts, Worcester
References
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.
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