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Treatment of Brain AVMs (TOBAS) Study

ConditionsUnruptured Brain Arteriovenous MalformationRuptured Brain Arteriovenous MalformationArteriovenous MalformationsAVMBAVM
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Any patient with a brain AVM

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neurosurgery

    Procedure/Surgery

    Surgical resection to be used when the lesion is considered by a multidisciplinary team to be safely 'operable'.

  • Radiation therapy

    Radiation

    when the AVM is smaller than 3 cm, and considered to not be safely 'operable'.

  • Embolization

    Procedure/Surgery

    Curative embolization, when the lesion is considered curable by embolization.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Interventional therapyActive comparator 3 interventions
Group B: Conservative management (medical management)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

composite event of death from any cause or disabling stroke

death or disabling stroke due to hemorrhage or infarction as revealed by imaging and resulting in mRS \>2.

Time frame
up to 10 years post-treatment (or randomization)

Secondary outcomes

1

occurrence of any neurological event

Time frame
within 10 years following treatment (or after randomization)
2

Permanent disabling peri-operative complications

The incidence of permanent (more than 3 months) disabling (mRS \>2) peri-operative (within 31 days) complications

Time frame
within 31 days post-treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre hospitalier de l'Université de Montréal (CHUM)

Lead sponsor

Centre Hospitalier Régional et Universitaire de Brest

Collaborator

Source ClinicalTrials.gov
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