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Treatment of Brain AVMs (TOBAS) Study
Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry
Who can join
Ages 5 and older · All sexes
Full eligibility 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.
About the study
The objectives of this study and registry are to offer the best management possible for patients with brain arteriovenous malformations (AVMs) (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (with endovascular procedures, neurosurgery, or radiotherapy, alone or in combination) or conservative management.
The trial has been designed to test a) whether medical management or interventional therapy will reduce the risk of death or debilitating stroke (due to hemorrhage or infarction) by an absolute magnitude of about 15% (over 10 years) for unruptured AVMs (from 30% to 15%); and, b) to test if endovascular treatment can improve the safety and efficacy of surgery or radiation therapy by at least 10% (80% to 90%).
As for the nested trial on the role of embolization in the treatment of Brain AVMs by other means: the pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures from 20% to 10%. In addition,embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8%.
What is being tested
- Neurosurgery (procedure)
- Radiation therapy (radiation)
- Embolization (procedure)
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM) · Participants: 1,000 · Started: 2014-05
Contact the study team
- Daniel Roy, MD · Phone: 514-890-8000
- Tim Darsaut, MD · Phone: 780-407-1440
Official record on ClinicalTrials.gov — NCT02098252
Locations in the U.S.
| Florida | Mayo Clinic in Jacksonville FL, Jacksonville |
| Massachusetts | Boston Medical Center, Boston |
| New Mexico | University of New Mexico Health Sciences Center, Albuquerque |
Conditions
- Arteriovenous Malformations
- Stroke
- Intracranial Hemorrhages
- Birth Defects
- Aneurysms
- Vascular Malformations
- Cardiovascular Disease
- Vascular Diseases
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.