Treatment of Brain AVMs (TOBAS) Study

Conditions

• AVM
• Arteriovenous Malformations
• BAVM
• Ruptured Brain Arteriovenous Malformation
• Unruptured Brain Arteriovenous Malformation

Eligibility Criteria

Sex

ALL

Age

5 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Neurosurgery — PROCEDURE
  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
  Curative embolization, when the lesion is considered curable by embolization.

Study Details

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%.

Key Dates

Start date

May 31, 2014

Status verified

Aug 2024

Primary completion

Jan 31, 2035

Completion

Jan 31, 2036

Study Design

Enrollment

1,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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.

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

• Daniel Roy, MD
  514-890-8000
  [email protected]
• Tim Darsaut, MD
  780-407-1440
  [email protected]

Locations (3)

Find similar trials in Jacksonville, FL

Related Studies

• Comprehensive HHT Outcomes Registry of the United States (CHORUS)
  Recruiting · Cure HHT · Birmingham, Alabama