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Treatment of Brain AVMs (TOBAS) Study (TOBAS)

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ClinicalTrials.gov Identifier: NCT02098252
Recruitment Status : Recruiting
First Posted : March 27, 2014
Last Update Posted : February 14, 2018
Sponsor:
Collaborator:
Centre Hospitalier Régional et Universitaire de Brest
Information provided by (Responsible Party):
Jean Raymond, Centre hospitalier de l'Université de Montréal (CHUM)

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%.


Condition or disease Intervention/treatment Phase
Unruptured Brain Arteriovenous Malformation Ruptured Brain Arteriovenous Malformation Arteriovenous Malformations AVM BAVM Procedure: Neurosurgery Radiation: Radiation therapy Procedure: Embolization Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry
Study Start Date : May 2014
Estimated Primary Completion Date : January 2035
Estimated Study Completion Date : January 2036

Arm Intervention/treatment
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.

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.

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 Measures :
  1. composite event of death from any cause or disabling stroke [ Time Frame: up to 10 years post-treatment (or randomization) ]
    death or disabling stroke due to hemorrhage or infarction as revealed by imaging and resulting in mRS >2.


Secondary Outcome Measures :
  1. occurrence of any neurological event [ Time Frame: within 10 years following treatment (or after randomization) ]
  2. Permanent disabling peri-operative complications [ Time Frame: within 31 days post-treatment ]
    The incidence of permanent (more than 3 months) disabling (mRS >2) peri-operative (within 31 days) complications



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02098252


Contacts
Contact: Jean Raymond, MD 514-890-8000 ext 27235 jraymond.nri@gmail.com
Contact: Tim Darsaut, MD 780-407-1440 tdarsaut@ualberta.ca

Locations
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Thanh Nguyen, MD       Thanh.Nguyen@bmc.org   
Canada, Quebec
Centre Hospitalier de l'Université de Montréal Recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Suzanne Nolet    514-890-8000 ext 26359    Suzanne.Nolet@crchum.qc.ca   
Contact: Ruby Klink, PhD    514-890-8000 ext 25245    Ruby.Klink@crchum.qc.ca   
Principal Investigator: Jean Raymond, MD         
Sub-Investigator: Daniel Roy, MD         
Sub-Investigator: Alain Weill, MD         
Sub-Investigator: Michel Bojanowski, MD         
Sub-Investigator: Chiraz Chaalala, MD         
Sub-Investigator: Jean-Paul Bahary, MD         
Sub-Investigator: David Roberge, MD         
Sub-Investigator: Laura Masucci, MD         
Sub-Investigator: Cynthia Ménard, MD         
Sub-Investigator: Christian Stapf, MD         
France
CHRU de Brest (Brest University Hospital) Recruiting
Brest, Bretagne, France, 29609
Contact: Elsa Magro, MD       elsa.magro@chu-brest.fr   
Principal Investigator: Elsa Magro, MD         
Principal Investigator: Jean-Christophe Gentric, MD         
Centre Hospit Régional Universitaire de Besançon Recruiting
Besançon, France, 25030
Contact: Alessandra Biondi, MD       biondi.alessandra@gmail.com   
Centre Hospitalier Universitaire de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Xavier Barreau, MD       xavier.barreau@chu-bordeaux.fr   
Centre Hospitalier Universitaire de Caen Recruiting
Caen, France, 14033
Contact: Patrick Courtheoux, MD       courtheoux-p@chu-caen.fr   
Centre Hospitalier Universitaire de Lyon Recruiting
Lyon, France, 69002
Contact: Francis Turjman, MD       drturjman@gmail.com   
Assistance Publique - Hôpitaux de Marseille Recruiting
Marseille, France, 13005
Contact: Pierre-Hugues Roche, MD       pierre-hugues.roche@ap-hm.fr   
Centre Hospitalier Universitaire de Montpellier Recruiting
Montpellier, France, 34000
Contact: Vincent Costalat, MD       vincentcost@hotmail.com   
Centre Hospitalier Régional Universitaire de Nancy Recruiting
Nancy, France, 54035
Contact: Serge Bracard, MD       s.bracard@chru-nancy.fr   
Centre Hospitalier Universitaire de Nantes Recruiting
Nantes, France, 44093
Contact: Hubert Desal, MD       hubert.desal@chu-nantes.fr   
Hôpital Universitaire Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Philippe Cornu, MD       philippe.cornu@psl.aphp.fr   
Fondation Ophtalmologique Rothschild Recruiting
Paris, France, 75019
Contact: Michel Piotin, MD       mpiotin@for.paris   
Centre Hospitalier Sainte-Anne Recruiting
Paris, France, 75674
Contact: Denis Trystram, MD       D.TRYSTRAM@ch-sainte-anne.fr   
Centre Hospitalier Universitaire de Rennes Recruiting
Rennes, France, 35033
Contact: Xavier Morandi, MD       xavier.morandi@chu-rennes.fr   
Centre Hospitalier Universitaire Hôpitaux de Rouen Recruiting
Rouen, France, 76130
Contact: Christine Papagiannaki, MD       c.papagiannaki@chu-rouen.fr   
Les Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67200
Contact: François Proust, MD       francois.proust@neurochirurgie.fr   
Centre Hospitalier Universitaire de Toulouse Recruiting
Toulouse, France, 70034
Contact: Christophe Cognard, MD       cognard.c@chu-toulouse.fr   
Centre Hospitalier Régional Universitaire de Tours Recruiting
Tours, France, 37000
Contact: Denis Herbreteau, MD       denis.herbreteau@univ-tours.fr   
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Centre Hospitalier Régional et Universitaire de Brest
Investigators
Principal Investigator: Jean Raymond, MD CHUM-Montreal

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean Raymond, Principal Investigator, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02098252     History of Changes
Other Study ID Numbers: 13.315
First Posted: March 27, 2014    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018

Keywords provided by Jean Raymond, Centre hospitalier de l'Université de Montréal (CHUM):
brain arteriovenous malformation
Arteriovenous Malformations
Congenital Abnormalities
Vascular Malformations
Cardiovascular Abnormalities
AVM
BAVM
Stroke
Intracranial Hemorrhage
Aneurysm
Cardiovascular Diseases
Vascular Diseases

Additional relevant MeSH terms:
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms