Researching AXIUM Coiling Experience and Recanalization (RACER)

Completed

Conditions studied: Aneurysms, Vascular Diseases, Cerebrovascular Disorders, Intracranial Arterial Diseases

In brief

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.

Key facts

Study ID

NCT00703794

Run by

Medtronic Neurovascular Clinical Affairs

People needed

119

Starts

2008-06-01

Expected to finish

2012-01-16

Last updated by the study team

2018-10-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Kaleida Health - Millard Fillmore — Buffalo, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, 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

Full record on ClinicalTrials.gov

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