A Randomized Trial of Unruptured Brain AVMs

Completed · Phase 3

Conditions studied: Arteriovenous Malformations, Cerebral

In brief

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.

Key facts

Study ID

NCT00389181

Run by

Columbia University

People needed

226

Starts

2006-10-01

Expected to finish

2015-05-01

Last updated by the study team

2015-06-04

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd — Los Angeles, California, United States
• University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza — Los Angeles, California, United States
• Kaiser Permanente (SF) — Redwood City, California, United States
• University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38 — San Francisco, California, United States
• University of Miami — Miami, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700 — Maywood, Illinois, United States
• University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive , — Iowa City, Iowa, United States
• Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road — Southfield, Michigan, United States
• St. Joseph's Regional Medical Center — Paterson, New Jersey, United States
• SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189 — Brooklyn, New York, United States
• Mercy Hospital of Buffalo — Buffalo, New York, United States
• Winthrop University Hospital — Mineola, New York, United States
• Long Island Jewish Medical Center — New Hyde Park, New York, United States
• Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136 — New York, New York, United States
• New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St — New York, New York, United States
• John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120, — Johnstown, Pennsylvania, United States
• Thomas Jefferson Hospital for Neuroscience — Philadelphia, Pennsylvania, United States
• Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street — Austin, Texas, United States
• University of Texas Medical School in Houston — Houston, Texas, United States
• University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212 — Charlottesville, Virginia, United States
• Sentara Medical Group — Norfolk, Virginia, United States
• Marshfield Clinic — Marshfield, Wisconsin, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• Barrow Neurological Institute, 350 West Thomas Road — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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