CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 226 enrolled
Drug / intervention
Interventional therapy +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00389181
NCT00389181Phase 3Completed
CompareCT.gov

A Randomized Trial of Unruptured Brain Arteriovenous Malformations

Columbia University·interventional·Posted Oct 18, 2006·Updated Jun 4, 2015

In Brief

A Phase 3 clinical trial evaluating Interventional therapy and Medical management for Arteriovenous Malformations, Cerebral. Completed, enrolled 226 participants across 66 sites in 14 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArteriovenous Malformations, Cerebral
CountriesAustralia, Austria, Brazil, Canada, Finland, France, Germany, Italy, Netherlands, South Korea, Spain, Switzerland, United Kingdom, United States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 18, 2006
Enrollment StartOct 1, 2006
Primary CompletionJun 1, 2013
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 19.7 years ago

Interventions

Interventional therapyprocedure

All interventional procedures are standard of care for the treatment of AVMs. They are not experimental. A patient randomized to interventional therapy is expected to begin interventional therapy within 3 months following randomization. Interventional therapy consists of endovascular attempts at occlusion of the nidus and feeding vessels, coiling or microsurgery for feeding artery aneurysms, microsurgery for BAVM itself, and radiosurgery, these alone or in various combinations and timings.

Medical managementother

Patients participating in the trial will receive the best medical management possible for the disorder being tested in the trial and for any general medical illnesses they are demonstrated to have. One important consideration in the medical management of patients in this trial is stroke risk factor reduction.