Compares treatments for abnormal tangles of blood vessels in the brain
Tests whether treating brain arteriovenous malformations lowers the risk of death or disabling stroke.
Plain-language title generated from the registry record
Registry title: Treatment of Brain AVMs (TOBAS) Study
Key facts
- Where
- Fortaleza and São Paulo, BrazilSee the 2 sites
Where in Brazil
- Hospital Geral de FortalezaFortaleza, BrazilTaking people
- Universidade Federal de Sao PauloSão Paulo, BrazilTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Centre hospitalier de l'Université de Montréal (CHUM)
- Trial code
- NCT02098252
- Record updated
- 15 August 2024
- Original description
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.Read full original descriptionShow less
Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry
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%.
Inclusion: Any patient with a brain AVM.
Exclusion: 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.