Recruiting

Brain AVMs

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT02098252

Conditions

Unruptured Brain Arteriovenous Malformation

Ruptured Brain Arteriovenous Malformation

Arteriovenous Malformations

AVM

BAVM

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

Interventions

Neurosurgery

Radiation therapy

Embolization

Study Details

Brief summary:

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%.

Conditions

Unruptured Brain Arteriovenous Malformation

Ruptured Brain Arteriovenous Malformation

Arteriovenous Malformations

AVM

BAVM

Study ID

NCT02098252

Start date

May, 2014

Status verified date

Aug, 2024

Completion date

Jan, 2036

Anticipated

Primary completion date

Jan, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 5+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Neurosurgery

Surgical resection to be used 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'.

Embolization

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

Primary outcome measure

  • composite event of death from any cause or disabling stroke [ Time Frame: up to 10 years post-treatment (or randomization) ]

Central Contacts and Locations

Central contacts

Daniel Roy, MD

514-890-8000daniel.roy.chum@ssss.gouv.qc.ca

Tim Darsaut, MD

780-407-1440tdarsaut@ualberta.ca

Locations

Mayo Clinic in Jacksonville FL

Recruiting

Jacksonville, Florida, United States

Contacts

Rabih Tawk, MD

Rabih.tawk@mayo.edu

Boston Medical Center

Recruiting

Boston, Massachusetts, United States, 02118

Contacts

Thanh Nguyen, MD

Thanh.Nguyen@bmc.org

University of New Mexico Health Sciences Center

Recruiting

Albuquerque, New Mexico, United States, 87131

Contacts

Andrew Carlson, MD

AndrewCarlson@salud.unm.edu

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada

Contacts

Tim Darsaut, MD, PhD

tdarsaut@ualberta.ca

Principal Investigator:

Tim Darsaut, MD, PhD

Klink, Ruby

Recruiting

Montreal, Quebec, Canada, H2L 4M1

Contacts

Ruby Klink, PhD

5148908000ruby.klink.chum@ssss.gouv.qc.ca

Ruby Klink, PhD

514-890-8000ruby.klink.chum@ssss.gouv.qc.ca

Principal Investigator:

Daniel Roy, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 15, 2024

Last verified

Aug, 2024

Keywords

  • brain arteriovenous malformation
  • Arteriovenous Malformations
  • AVM
  • BAVM
  • Stroke
  • Intracranial Hemorrhage
  • Congenital Abnormalities
  • Aneurysm
  • Vascular Malformations
  • Cardiovascular Abnormalities
  • Cardiovascular Diseases
  • Vascular Diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-08-15.