What is this study trying to find out about brain arteriovenous malformations?

This study aims to find the best management approach for brain AVMs by comparing medical management with various interventional therapies to reduce death or disabling stroke risk over 10 years. It also evaluates whether embolization before surgery or radiosurgery improves treatment safety and success. The study is led by the Centre hospitalier de l'Université de Montréal.

Who may be eligible for this brain AVM clinical trial?

Participants must be at least 5 years old with a diagnosed brain AVM. There is no gender restriction. Patients who have had a brain hemorrhage causing mass effect requiring immediate surgery are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this brain AVM clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase Not Applicable

Age: 5Years +

All Genders

ID02098252

Study on Treatment Options for Brain Arteriovenous Malformations AVMs Including Surgery, Radiation, and Embolization Versus Medical Management

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-08-15

1000

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the best ways to manage patients with brain arteriovenous malformations AVMs, whether these AVMs have caused bleeding ruptured or not unruptured. The study aims to compare medical conservative management with interventional treatments like neurosurgery, radiation therapy, radiosurgery, and endovascular procedures to see which approach better reduces the risk of death or disabling stroke over 10 years. There is also a nested trial to evaluate whether embolization before surgery or radiosurgery improves treatment success and safety. The interventional therapies studied include surgical removal of the AVM when it is safely operable, radiation therapy for smaller AVMs less than 3 cm that cannot be safely operated on, radiosurgery, and curative embolization. Patients judged by a multidisciplinary team to possibly benefit from endovascular treatment before surgery or radiation may be randomly assigned to receive embolization or not. The conservative group receives medical management for symptoms, and if bleeding or infarction occurs, they may become candidates for interventional therapy. Participants will be followed for up to 10 years to monitor outcomes such as death from any cause or disabling stroke, measured by the Rankin Scale. The study will track neurological events, treatment complications, and the success of AVM occlusion. Researchers will regularly assess participants neurological status and adverse events. This long-term follow-up aims to provide clearer guidance on the safest and most effective management strategies for brain AVMs.

CONDITIONS

Brief Title

Treatment of Brain AVMs (TOBAS) Study

How This Trial Compares With Other Options

This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.

Factors	Interventional Therapy	Conservative Management
What it is	Active treatment for brain AVMs using neurosurgery, stereotactic radiation therapy, or curative embolization. The specific option is determined by a multidisciplinary team, considering the AVM's size, location, and operability.	Non-interventional approach involving medical management such as observation, control of symptoms (e.g., seizures), and blood pressure monitoring. No surgery, radiation, or embolization is performed.
Role in trial	Active comparator arm, assigned to receive one of the procedure-based therapies based on suitability.	Control comparator, assigned to conservative follow-up and medical symptom management without procedural intervention.
Primary use	Aims to eliminate or reduce the risk of hemorrhage and neurological complications by removing or obliterating the AVM with surgery, focused radiation, or embolization.	Aims to minimize intervention-related risks by managing symptoms medically, observing for changes, and attempting to prevent hemorrhage without active AVM removal.
How it is given or performed	Participants are evaluated by a multidisciplinary team. Depending on AVM characteristics, they may have surgical resection, radiation therapy if the AVM is small and inoperable, or embolization if curative.	Participants receive routine medical care, seizure and blood pressure management, and regular imaging or neurological follow-up. No procedural therapy is performed.
Evidence status	Interventional therapy is supported by randomized trials and meta-analyses, but outcomes vary by AVM features. Procedural risks include perioperative stroke, hemorrhage, or disability. Data is mixed on net benefit, especially for unruptured AVMs.	Conservative (non-interventional) management shows favorable outcomes in some studies, with lower risks of procedure-related complications but inherent risk of spontaneous hemorrhage over time.
Important risks	Risks include disabling stroke, death, perioperative hemorrhage, neurological deficits, and complications related to surgery, radiation, or embolization.	Risks include spontaneous AVM rupture leading to hemorrhage, stroke, disability, or death, though no added procedure-related risk is present.
Important limitations	Benefit-risk balance is unclear for unruptured AVMs; procedures carry a significant risk of new disability, and benefit varies by AVM type and patient selection. Long-term benefit over conservative management remains debated.	Observation does not eliminate lifelong risk of spontaneous hemorrhage or stroke from AVMs. Not all patients are suitable for non-interventional management, especially after rupture or in high-risk AVMs.

Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.

Who Can Participate

Age: 5Years +

All Genders

Eligibility Criteria

You may qualify if you...

Any patient with a brain arteriovenous malformation (AVM)

You will not qualify if you...

Hemorrhagic presentation with mass effect requiring surgical management. If a residual AVM is found after initial surgery, the patient may then be eligible for this study

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Varies based on treatment type and patient condition

Participants receive interventional therapies such as neurosurgery, radiation therapy, radiosurgery, and/or embolization, or conservative medical management as determined by the treating physician and multidisciplinary team.

Visit schedule varies depending on treatment modality and patient needs

Follow-up

Duration - Up to 10 years

Participants are followed for up to 10 years post-treatment or post-randomization to monitor for neurological events, treatment outcomes, and overall health status.

Regular follow-up visits scheduled over 10 years