Status:
COMPLETED
A Randomized Trial of Unruptured Brain AVMs
Lead Sponsor:
Columbia University
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Arteriovenous Malformations, Cerebral
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.
Detailed Description
Brain arteriovenous malformations (BAVMs) are an infrequent but important cause of stroke, particularly in a young population. Current invasive treatment strategies are varied and include endovascular...
Eligibility Criteria
Inclusion
- Patient must have unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram
- Patient must be 18 years of age or older
- Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms
Exclusion
- Patient has BAVM presenting with evidence of recent or prior hemorrhage
- Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)
- Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicates any interventional therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons)
- Patient has baseline Rankin ≥2
- Patient has concomitant disease reducing life expectancy to less than 10 years
- Patient has thrombocytopenia (\< 100,000/μL),
- Patient has uncorrectable coagulopathy (INR\>1.5)
- Patient is pregnant or lactating
- Patient has known allergy against iodine contrast agents
- Patient has multiple-foci BAVMs
- Patient has any form of arteriovenous or spinal fistulas
- Previous diagnosis of any of the following -
- Patient has a diagnosed Vein of Galen type malformation
- Patient has a diagnosed cavernous malformation
- Patient has a diagnosed dural arteriovenous fistula
- Patient has a diagnosed venous malformation
- Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome
- Patient has diagnosed BAVMs in context of moya-moya-type changes
- Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
226 Patients enrolled
Trial Details
Trial ID
NCT00389181
Start Date
October 1 2006
End Date
May 1 2015
Last Update
June 4 2015
Active Locations (66)
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1
Barrow Neurological Institute, 350 West Thomas Road
Phoenix, Arizona, United States, 85013
2
Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd
Los Angeles, California, United States, 90027
3
University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza
Los Angeles, California, United States, 90095-1769
4
Kaiser Permanente (SF)
Redwood City, California, United States, 94063