Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Procedure, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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%.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: f
View:

• Any patient with a brain AVM

Locations
United States
Florida
Mayo Clinic in Jacksonville FL
RECRUITING
Jacksonville
Massachusetts
Boston Medical Center
RECRUITING
Boston
New Mexico
University of New Mexico Health Sciences Center
RECRUITING
Albuquerque
Other Locations
Brazil
Hospital Geral de Fortaleza
RECRUITING
Fortaleza
Universidade Federal de Sǎo Paulo
RECRUITING
São Paulo
Canada
University of Alberta Hospital
RECRUITING
Edmonton
Klink, Ruby
RECRUITING
Montreal
Chile
Instituto de Neurocirugia Dr. A. Asenjo
RECRUITING
Santiago
Colombia
Universidad Autonoma de Bucaramanga
RECRUITING
Bucaramanga
France
Centre Hospit Régional Universitaire de Besançon
RECRUITING
Besançon
Centre Hospitalier Universitaire de Bordeaux
RECRUITING
Bordeaux
CHRU de Brest (Brest University Hospital)
RECRUITING
Brest
Centre Hospitalier Universitaire de Caen
RECRUITING
Caen
CHU Clermont-Ferrand
RECRUITING
Clermont-ferrand
CHU Dijon Bourgogne
RECRUITING
Dijon
Hôpital Bicêtre AP-HP
RECRUITING
Le Kremlin-bicêtre
CHU Limoges
RECRUITING
Limoges
Centre Hospitalier Universitaire de Lyon
RECRUITING
Lyon
Assistance Publique - Hôpitaux de Marseille
RECRUITING
Marseille
Centre Hospitalier Universitaire de Montpellier
RECRUITING
Montpellier
Centre Hospitalier Régional Universitaire de Nancy
RECRUITING
Nancy
Centre Hospitalier Universitaire de Nantes
RECRUITING
Nantes
Centre Hospitalier Sainte-Anne
RECRUITING
Paris
Fondation Ophtalmologique Rothschild
RECRUITING
Paris
Hôpital Universitaire Pitié-Salpêtrière
RECRUITING
Paris
Centre Hospitalier Universitaire de Rennes
RECRUITING
Rennes
Centre Hospitalier Universitaire Hôpitaux de Rouen
RECRUITING
Rouen
Les Hôpitaux Universitaires de Strasbourg
RECRUITING
Strasbourg
Centre Hospitalier Universitaire de Toulouse
RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Tours
RECRUITING
Tours
Contact Information
Primary
Daniel Roy, MD
daniel.roy.chum@ssss.gouv.qc.ca
514-890-8000
Backup
Tim Darsaut, MD
tdarsaut@ualberta.ca
780-407-1440
Time Frame
Start Date: 2014-05
Estimated Completion Date: 2036-01
Participants
Target number of participants: 1000
Treatments
Active_comparator: Interventional therapy
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.
No_intervention: Conservative management (medical management)
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.
Related Therapeutic Areas
Sponsors
Collaborators: Centre Hospitalier Régional et Universitaire de Brest
Leads: Centre hospitalier de l'Université de Montréal (CHUM)

This content was sourced from clinicaltrials.gov