Multimodal Therapy for Brain AVM (TOBAS Trial)

N/A

Recruiting

Led By Daniel Roy, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Any patient with a brain AVM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years post-treatment (or randomization)

Awards & highlights

No Placebo-Only Group

Summary

This trial is designed to improve long-term outcomes for patients with brain arteriovenous malformations by testing different therapies.

Who is the study for?

The TOBAS study is for patients with brain arteriovenous malformations (AVMs), which are tangles of abnormal blood vessels connecting arteries and veins in the brain. It's open to all such patients, except those needing urgent surgery due to bleeding effects from AVM.

What is being tested?

This trial explores whether medical management or interventional therapies like embolization, neurosurgery, or radiation—alone or combined—can significantly reduce death/stroke risks in AVM patients over a decade. It also examines if pre-treatment embolization can enhance the success of other treatments.

What are the potential side effects?

Potential side effects include complications from endovascular procedures, surgical risks associated with neurosurgery, and typical reactions to radiation therapy. The goal is an acceptable risk level of permanent disabling neurological issues at 8%.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a brain AVM.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years post-treatment (or randomization)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years post-treatment (or randomization)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years post-treatment (or randomization) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

composite event of death from any cause or disabling stroke

Secondary study objectives

Permanent disabling peri-operative complications

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Interventional therapyActive Control3 Interventions

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.

Group II: Conservative management (medical management)Active Control1 Intervention

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.

0 / 1Eligibility criteria met