Treatment options for brain arteriovenous malformations
Official title: Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry
Run by Centre hospitalier de l'Université de Montréal (CHUM) · NCT02098252 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 5 Years and up |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Drugs / interventions | radiation |
| Locations | 30 sites (Jacksonville, Florida and 29 other locations) |
| Status | Recruiting |
| Started | May 2014 |
| Main results expected | January 2035 |
| Study ends | January 2036 |
| Registry record updated | August 15, 2024 |
| Trial ID | NCT02098252 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study include any patient diagnosed with a brain AVM, whether it is ruptured or unruptured.
✕Probably not a fit
Patients with a hemorrhagic presentation requiring immediate surgical intervention may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies have shown promise in managing brain AVMs with interventional therapies, but this study's comprehensive approach is relatively novel.
Who can join: the full rules
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 it's running
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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
Show 24 more locations
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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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Exploratory look at brain blood flow and metabolism before and after removing unruptured AVMs
This study tests brain perfusion and metabolism with PET imaging and neuropsychological tests in adults before and six months after surgical treatment for unruptured brain AVMs.
-
Observational study on patients undergoing endovascular treatment for vascular conditions
This study looks at patients of all ages getting endovascular treatment for brain or spine blood vessel issues to see how they do before and after the procedure and to find out what might affect their recovery.
-
Evaluating outcomes in neurosurgery using standardized measures
This study is trying to see how different factors affect the results of brain surgeries by collecting information from patients before and after their operations.
-
Registry for patients with Hereditary Hemorrhagic Telangiectasia
This study is collecting information from people with Hereditary Hemorrhagic Telangiectasia to better understand the condition and help improve treatments in the future.
-
Targeted therapies for patients with vascular malformations
This study is testing new targeted treatments for patients with slow-flow and fast-flow vascular malformations to see if they work better than the usual therapies.
-
Evaluating the safety and usability of BALT medical devices for various brain and vascular conditions
This study is testing how safe and effective BALT medical devices are for treating brain and blood vessel conditions like aneurysms and strokes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.