Treatment of Brain AVMs (TOBAS) Study (TOBAS)
Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation, Arteriovenous Malformations
About this trial
This is an interventional treatment trial for Unruptured Brain Arteriovenous Malformation focused on measuring brain arteriovenous malformation, Arteriovenous Malformations, AVM, BAVM, Stroke, Intracranial Hemorrhage, Congenital Abnormalities, Aneurysm, Vascular Malformations, Cardiovascular Abnormalities, Cardiovascular Diseases, Vascular Diseases
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.
Sites / Locations
- Mayo Clinic in Jacksonville FLRecruiting
- Boston Medical CenterRecruiting
- University of New Mexico Health Sciences CenterRecruiting
- Hospital Geral de FortalezaRecruiting
- Universidade Federal de Sǎo PauloRecruiting
- University of Alberta HospitalRecruiting
- Klink, RubyRecruiting
- Instituto de Neurocirugia Dr. A. AsenjoRecruiting
- Universidad Autonoma de BucaramangaRecruiting
- CHRU de Brest (Brest University Hospital)Recruiting
- Centre Hospit Régional Universitaire de BesançonRecruiting
- Centre Hospitalier Universitaire de BordeauxRecruiting
- Centre Hospitalier Universitaire de CaenRecruiting
- CHU Clermont-FerrandRecruiting
- CHU Dijon BourgogneRecruiting
- Hôpital Bicêtre AP-HPRecruiting
- CHU LimogesRecruiting
- Centre Hospitalier Universitaire de LyonRecruiting
- Assistance Publique - Hôpitaux de MarseilleRecruiting
- Centre Hospitalier Universitaire de MontpellierRecruiting
- Centre Hospitalier Régional Universitaire de NancyRecruiting
- Centre Hospitalier Universitaire de NantesRecruiting
- Hôpital Universitaire Pitié-SalpêtrièreRecruiting
- Fondation Ophtalmologique RothschildRecruiting
- Centre Hospitalier Sainte-AnneRecruiting
- Centre Hospitalier Universitaire de RennesRecruiting
- Centre Hospitalier Universitaire Hôpitaux de RouenRecruiting
- Les Hôpitaux Universitaires de StrasbourgRecruiting
- Centre Hospitalier Universitaire de ToulouseRecruiting
- Centre Hospitalier Régional Universitaire de ToursRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
No Intervention
Interventional therapy
Conservative management (medical management)
Interventional therapies include: neurosurgery (surgical resection when the lesion is considered by a multidisciplinary team to be safely 'operable'); radiation therapy (when the AVM is smaller than 3 cm, and considered to not be safely 'operable'); radiosurgery, alone or in combination, with or without endovascular procedure; curative embolization (when the lesion is considered curable by embolization). Patients with AVMs that the multidisciplinary team judges could potentially benefit from endovascular treatment prior to surgical resection or radiation therapy will then also be pre-randomly allocated to embolization or to no embolization.
The conservative, or medical management arm, involves pharmacological therapy as deemed appropriate for medical symptoms as determined by the treating investigator. Should patients in the conservative management arm develop hemorrhage or infarction related to their AVM, they then potentially become candidates for interventional therapy.