MedTrace Logo

Treatment of Brain AVMs (TOBAS) Study

NCT02098252 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1000

Last updated 2024-08-15

No results posted yet for this study

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

Interventions

PROCEDURE

Neurosurgery

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

RADIATION

Radiation therapy

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

PROCEDURE

Embolization

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

Sponsors & Collaborators

  • Centre Hospitalier Régional et Universitaire de Brest

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Daniel Roy, MD · CHUM-Montreal

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2035-01-31
Completion
2036-01-31

Countries

  • United States
  • Brazil
  • Canada
  • Chile
  • Colombia
  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02098252 on ClinicalTrials.gov