Treatment options for brain arteriovenous malformations
Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry
NA · Centre hospitalier de l'Université de Montréal (CHUM) · NCT02098252
This study is testing different treatment options for people with brain arteriovenous malformations to see which ones work best in preventing serious problems like stroke or death over ten years.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (other) |
| Drugs / interventions | radiation |
| Locations | 30 sites (Jacksonville, Florida and 29 other locations) |
| Trial ID | NCT02098252 on ClinicalTrials.gov |
What this trial studies
This study aims to determine the best management strategies for patients with brain arteriovenous malformations (AVMs), whether they are ruptured or unruptured. It will evaluate the effectiveness of medical management versus interventional therapies, including neurosurgery, radiation therapy, and embolization, in reducing the risk of death or debilitating stroke over a 10-year period. The study also seeks to assess if pre-surgical embolization can enhance the safety and efficacy of subsequent treatments. By analyzing long-term outcomes, the study hopes to provide clearer guidance on managing AVMs.
Who should consider this trial
Good fit: Ideal candidates for this study include any patient diagnosed with a brain AVM, whether it is ruptured or unruptured.
Not a fit: Patients with a hemorrhagic presentation requiring immediate surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the risk of death and disability for patients with brain AVMs.
How similar studies have performed: Other studies have shown promise in managing brain AVMs with interventional therapies, but this study's comprehensive approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient with a brain AVM Exclusion Criteria: * Hemorrhagic presentation with mass effect requiring surgical management. In these cases, if a residual AVM is found after the initial surgery, the patient could then be a candidate for TOBAS.
Where this trial is running
Jacksonville, Florida and 29 other locations
- Mayo Clinic in Jacksonville FL — Jacksonville, Florida, United States (RECRUITING)
- Boston Medical Center — Boston, Massachusetts, United States (RECRUITING)
- University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (RECRUITING)
- Hospital Geral de Fortaleza — Fortaleza, Brazil (RECRUITING)
- Universidade Federal de Sǎo Paulo — São Paulo, Brazil (RECRUITING)
- University of Alberta Hospital — Edmonton, Alberta, Canada (RECRUITING)
- Klink, Ruby — Montreal, Quebec, Canada (RECRUITING)
- Instituto de Neurocirugia Dr. A. Asenjo — Santiago, Chile (RECRUITING)
- Universidad Autonoma de Bucaramanga — Bucaramanga, Colombia (RECRUITING)
- CHRU de Brest (Brest University Hospital) — Brest, Brittany Region, France (RECRUITING)
- Centre Hospit Régional Universitaire de Besançon — Besançon, France (RECRUITING)
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (RECRUITING)
- Centre Hospitalier Universitaire de Caen — Caen, France (RECRUITING)
- CHU Clermont-Ferrand — Clermont-Ferrand, France (RECRUITING)
- CHU Dijon Bourgogne — Dijon, France (RECRUITING)
- Hôpital Bicêtre AP-HP — Le Kremlin-Bicêtre, France (RECRUITING)
- CHU Limoges — Limoges, France (RECRUITING)
- Centre Hospitalier Universitaire de Lyon — Lyon, France (RECRUITING)
- Assistance Publique - Hôpitaux de Marseille — Marseille, France (RECRUITING)
- Centre Hospitalier Universitaire de Montpellier — Montpellier, France (RECRUITING)
- Centre Hospitalier Régional Universitaire de Nancy — Nancy, France (RECRUITING)
- Centre Hospitalier Universitaire de Nantes — Nantes, France (RECRUITING)
- Hôpital Universitaire Pitié-Salpêtrière — Paris, France (RECRUITING)
- Fondation Ophtalmologique Rothschild — Paris, France (RECRUITING)
- Centre Hospitalier Sainte-Anne — Paris, France (RECRUITING)
- Centre Hospitalier Universitaire de Rennes — Rennes, France (RECRUITING)
- Centre Hospitalier Universitaire Hôpitaux de Rouen — Rouen, France (RECRUITING)
- Les Hôpitaux Universitaires de Strasbourg — Strasbourg, France (RECRUITING)
- Centre Hospitalier Universitaire de Toulouse — Toulouse, France (RECRUITING)
- Centre Hospitalier Régional Universitaire de Tours — Tours, France (RECRUITING)
Study contacts
- Principal investigator: Daniel Roy, MD — CHUM-Montreal
- Study coordinator: Daniel Roy, MD
- Email: daniel.roy.chum@ssss.gouv.qc.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation, Arteriovenous Malformations, AVM, BAVM, brain arteriovenous malformation, Stroke, Intracranial Hemorrhage