Treatment of Brain AVMs (TOBAS) 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%.
Unruptured Brain Arteriovenous Malformation
Ruptured Brain Arteriovenous Malformation
Radiation: Radiation therapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry|
- composite event of death from any cause or disabling stroke [ Time Frame: up to 10 years post-treatment (or randomization) ] [ Designated as safety issue: Yes ]death or disabling stroke due to hemorrhage or infarction as revealed by imaging and resulting in mRS >2.
- occurrence of any neurological event [ Time Frame: within 10 years following treatment (or after randomization) ] [ Designated as safety issue: Yes ]
- Permanent disabling peri-operative complications [ Time Frame: within 31 days post-treatment ] [ Designated as safety issue: Yes ]The incidence of permanent (more than 3 months) disabling (mRS >2) peri-operative (within 31 days) complications
|Study Start Date:||May 2014|
|Estimated Primary Completion Date:||January 2035 (Final data collection date for primary outcome measure)|
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.
Surgical resection to be used when the lesion is considered by a multidisciplinary team to be safely 'operable'.Radiation: Radiation therapy
when the AVM is smaller than 3 cm, and considered to not be safely 'operable'.Procedure: Embolization
Curative embolization, when the lesion is considered curable by 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02098252
|Contact: Jean Raymond, MD||514-890-8000 ext email@example.com|
|Contact: Tim Darsaut, MDfirstname.lastname@example.org|
|Centre Hospitalier de l'Université de Montréal||Recruiting|
|Montreal, Quebec, Canada, H2L 4M1|
|Contact: Suzanne Nolet 514-890-8000 ext 26359 Suzanne.Nolet@crchum.qc.ca|
|Contact: Ruby Klink, PhD 514-890-8000 ext 25245 Ruby.Klink@crchum.qc.ca|
|Principal Investigator: Jean Raymond, MD|
|Sub-Investigator: Daniel Roy, MD|
|Sub-Investigator: Alain Weill, MD|
|Sub-Investigator: Michel Bojanowski, MD|
|Sub-Investigator: Chiraz Chaalala, MD|
|Sub-Investigator: Jean-Paul Bahary, MD|
|Sub-Investigator: David Roberge, MD|
|Sub-Investigator: Laura Masucci, MD|
|Principal Investigator:||Jean Raymond, MD||CHUM-Montreal|