CompletedPhase 3

A Randomized Trial of Unruptured Brain AVMs

United States226 participantsStarted 2006-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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

What they're measuring

Difference of 5-year event rates between two arms

Timeframe: 5 years

Trial details

NCT IDNCT00389181

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-06

View on ClinicalTrials.gov More Arteriovenous Malformations, Cerebral trials