A Randomized Trial of Unruptured Brain AVMs

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.

Conditions

• Arteriovenous Malformations, Cerebral

Interventions

PROCEDURE

Interventional therapy

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.

OTHER

Medical management

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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• J.P. Mohr, MS, MD · Stroke Center/The Neurological Institute, Columbia University

• Alan J. Moskowitz, MD · InCHOIR, Department of Health Policy, Mount Sinai School of Medicine

• Michael Parides, PhD · InCHOIR, Department of Health Policy, Mount Sinai School of Medicine, Co-PI

• Christian Stapf, MD · Clinical Coordinating Center, Europe

• Eric Vicaut, MD · Clinical Coordinating Center, Europe, Co-PI

• Claudia S. Moy, PhD · NINDS, Co-PI

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-10-31

Primary Completion

2013-06-30

Completion

2015-05-31

Countries

• United States
• Australia
• Austria
• Brazil
• Canada
• Finland
• France
• Germany
• Italy
• Netherlands
• South Korea
• Spain
• Switzerland
• United Kingdom

Study Locations