Treatment of Brain AVMs (TOBAS) Study

Recruiting now · Not applicable

Conditions studied: Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation, Arteriovenous Malformations, AVM, BAVM

In brief

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 facts

Study ID

NCT02098252

Run by

Centre hospitalier de l'Université de Montréal (CHUM)

People needed

1000

Starts

2014-05-01

Expected to finish

2036-01-01

Last updated by the study team

2024-08-15

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Any patient with a brain AVM

You may not qualify if…

• 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.

Where it is running

• Mayo Clinic in Jacksonville FL — Jacksonville, Florida, United States (enrolling)
• Boston Medical Center — Boston, Massachusetts, United States (enrolling)
• University of New Mexico Health Sciences Center — Albuquerque, New Mexico, United States (enrolling)
• Hospital Geral de Fortaleza — Fortaleza, Brazil (enrolling)
• Universidade Federal de Sǎo Paulo — São Paulo, Brazil (enrolling)
• University of Alberta Hospital — Edmonton, Alberta, Canada (enrolling)
• Klink, Ruby — Montreal, Quebec, Canada (enrolling)
• Instituto de Neurocirugia Dr. A. Asenjo — Santiago, Chile (enrolling)
• Universidad Autonoma de Bucaramanga — Bucaramanga, Colombia (enrolling)
• CHRU de Brest (Brest University Hospital) — Brest, Brittany Region, France (enrolling)
• Centre Hospit Régional Universitaire de Besançon — Besançon, France (enrolling)
• Centre Hospitalier Universitaire de Bordeaux — Bordeaux, France (enrolling)
• Centre Hospitalier Universitaire de Caen — Caen, France (enrolling)
• CHU Clermont-Ferrand — Clermont-Ferrand, France (enrolling)
• CHU Dijon Bourgogne — Dijon, France (enrolling)
• Hôpital Bicêtre AP-HP — Le Kremlin-Bicêtre, France (enrolling)
• CHU Limoges — Limoges, France (enrolling)
• Centre Hospitalier Universitaire de Lyon — Lyon, France (enrolling)
• Assistance Publique - Hôpitaux de Marseille — Marseille, France (enrolling)
• Centre Hospitalier Universitaire de Montpellier — Montpellier, France (enrolling)
• Centre Hospitalier Régional Universitaire de Nancy — Nancy, France (enrolling)
• Centre Hospitalier Universitaire de Nantes — Nantes, France (enrolling)
• Hôpital Universitaire Pitié-Salpêtrière — Paris, France (enrolling)
• Fondation Ophtalmologique Rothschild — Paris, France (enrolling)
• Centre Hospitalier Sainte-Anne — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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