Clinical Research Directory
Browse clinical research sites, groups, and studies.
Treatment of Brain AVMs (TOBAS) Study
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Summary
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%.
Official title: Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry
Key Details
Gender
All
Age Range
5 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2014-05
Completion Date
2036-01
Last Updated
2024-08-15
Healthy Volunteers
No
Conditions
Interventions
Neurosurgery
Surgical resection to be used 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'.
Embolization
Curative embolization, when the lesion is considered curable by embolization.
Locations (30)
Mayo Clinic in Jacksonville FL
Jacksonville, Florida, United States
Boston Medical Center
Boston, Massachusetts, United States
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Hospital Geral de Fortaleza
Fortaleza, Brazil
Universidade Federal de Sǎo Paulo
São Paulo, Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
Klink, Ruby
Montreal, Quebec, Canada
Instituto de Neurocirugia Dr. A. Asenjo
Santiago, Chile
Universidad Autonoma de Bucaramanga
Bucaramanga, Colombia
CHRU de Brest (Brest University Hospital)
Brest, Brittany Region, France
Centre Hospit Régional Universitaire de Besançon
Besançon, France
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Centre Hospitalier Universitaire de Caen
Caen, France
CHU Clermont-Ferrand
Clermont-Ferrand, France
CHU Dijon Bourgogne
Dijon, France
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, France
CHU Limoges
Limoges, France
Centre Hospitalier Universitaire de Lyon
Lyon, France
Assistance Publique - Hôpitaux de Marseille
Marseille, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Centre Hospitalier Régional Universitaire de Nancy
Nancy, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Hôpital Universitaire Pitié-Salpêtrière
Paris, France
Fondation Ophtalmologique Rothschild
Paris, France
Centre Hospitalier Sainte-Anne
Paris, France
Centre Hospitalier Universitaire de Rennes
Rennes, France
Centre Hospitalier Universitaire Hôpitaux de Rouen
Rouen, France
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Centre Hospitalier Régional Universitaire de Tours
Tours, France