Status:
COMPLETED
Researching AXIUM Coiling Experience and Recanalization (RACER)
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Aneurysms
Vascular Diseases
Eligibility:
All Genders
18+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 16 2012
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT00703794
Start Date
June 1 2008
End Date
January 16 2012
Last Update
October 29 2018
Active Locations (18)
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1
Lac+Usc/Uscuh
Los Angeles, California, United States, 90089
2
Vascular and Interventional Specialists of Orange County, Inc. - St. Joseph Hospital of Orange
Orange, California, United States, 92868
3
Lee Memorial Health System
Fort Myers, Florida, United States, 33908
4
University of Miami - Jackson Memorial Hospital Systems
Miami, Florida, United States, 33136