No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
5 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
1,000 (estimated)
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM) · Other
Who this trial is looking for
This trial is looking for patients with brain arteriovenous malformations (AVMs) that may or may not have bled. Participants may receive different treatments, including surgery or other procedures, to find the best way to manage their condition.
Are You a Good Fit for This Trial?
You may be able to join if
I have a brain AVM
You may not be able to join if
I have had bleeding that requires surgery
I have a mass effect from my AVM requiring surgical management
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
T…
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%.
Trial Locations
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City
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Status
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.
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.
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