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 : June 10, 2022

See Contacts and Locations

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborator:

Centre Hospitalier Régional et Universitaire de Brest

Information provided by (Responsible Party):

Centre hospitalier de l'Université de Montréal (CHUM)

Study Description

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

Detailed Description:

Intracranial arteriovenous malformations (AVMs) are relatively uncommon but increasingly discovered lesions that can lead to significant neurological disability or death.1 Population-based data suggest that the annual incidence of discovery of a symptomatic AVM is approximately 1.1 per 100 000 population.7. AVMs commonly present following an intracranial hemorrhage or seizure, although with contemporary brain imaging techniques, an increasing number of incidental lesions are found.2

Intracranial AVMs are typically diagnosed before the age of 40 years old, with more than 50% of patients presenting following an intracranial hemorrhage, the most feared sequelae of harbouring an AVM.3 An AVM-related seizure is reported as the presenting feature in 20-25% of cases4, 5 and although these can sometimes be successfully managed with anti-epileptic agents, some AVMs lead to intractable seizures in spite of medication. Other presentations include headaches, focal neurological deficits, or pulsatile tinnitus.1

The available natural history studies indicate an overall risk of initial hemorrhage of approximately 2% to 4% per year, although the long-term consequences in terms of the probability of death or long-term disability following intracranial hemorrhage remains unclear.6-8 Mortality from the first hemorrhage has been reported to occur between 10-30% of patients with a ruptured AVM, although some more recent data suggest that the mortality rate may be lower and only 10-20% of survivors have long-term disability.9-11 Hemorrhagic presentation is considered the most reliable risk factor for a repeat hemorrhage.6, 8 Unfortunately, the natural history data available is not of sufficient quality (Level V) to support making management recommendations.

Over the last decade, there have been substantial developments in the management of intracranial AVMs. There has been an evolution of microsurgical as well as endovascular and radiosurgical techniques to treat these lesions. As the management options have evolved, individual and combined modality treatment protocols have been developed in different institutions for the management of AVMs. Current interventional therapy for brain arteriovenous malformations (BAVMs) is varied and includes open neurosurgical resection, radiosurgery, and endovascular management, either alone or in combination. The choice of management is largely dependent on the decisions of the local physicians that make up the treatment team, and a recent survey has demonstrated substantial variability in decision-making for almost all AVMs.12

Interventional therapies, when they are performed, are assumed to decrease the risk of initial or subsequent hemorrhage and therefore lead to better long-term outcomes, an assumption that has yet to be proven.

Although the question of which AVM treatment modality is the most appropriate first choice (surgery, radiosurgery, or embolization) remains controversial, consensus can be reached in several circumstances. Surgical evacuation of a hematoma exerting significant mass effect is an uncontested appropriate management, although many patients with a hemorrhagic presentation do not necessarily meet this threshold for surgical indication. Almost all other management choices remain debatable.13, 14 A systematic review has proposed that approximately 7.1% of surgical candidates, 6.6% of endovascular candidates, and 5.1% of radiosurgical candidates were facing permanent neurological deficits after treatment.15 The epidemiological study of Davies et al, using the Nationwide Inpatient Sample (NIS) data base and surrogates such as location at discharge, showed worse outcomes for surgical and endovascular management of both ruptured and unruptured AVMs.16

Current choices of interventional therapy for brain arteriovenous malformations are varied, with decisions made on a case-by-case basis, by the local clinical team. Often these decisions will change as the results of one particular attempted treatment modality become available. All interventional therapies are performed with the assumption that they will decrease the risk of initial or subsequent hemorrhage and lead to better long-term patient outcomes. Despite these laudable goals, there is no reliable evidence that interventional management of unruptured bAVMs is beneficial, and in patients judged to need interventional therapy, such as those patients presenting with ruptures, there is no randomized evidence that embolization is beneficial. Although no clinical trial data exist on the effect of interventional therapy even after AVM hemorrhage, the most contentious issue at present is whether interventional therapy should be considered for patients with incidentally discovered AVMs, whose lesions have not bled. In patients with unruptured AVMs, the best management strategy remains unknown, and interventions should be proposed only in the context of a randomized trial.

The potential role of embolization: Although endovascular AVM embolization can occasionally eradicate lesions without surgery or radiation therapy in selected cases, and although embolization may potentially improve the safety and efficacy of surgical or radiosurgical treatments in some other cases, it remains a contentious issue whether it is worth accepting the additional risks of endovascular treatment for a greater overall benefit for patients with brain AVMs that are treatable by surgery or radiation therapy. Some series have reported satisfactory results.20 It is possible that the overall morbidity and mortality of the combined interventional management strategy is increased when embolization is added to a surgical or radiosurgical procedure.17 Therefore, pre-surgical or pre-radiosurgical embolization can be offered, but only as a randomized allocation between embolization and no embolization, within the context of a trial.

Primary objective: In the spirit of care trials, the primary objective of the trial and accompanying registry is to offer the best management possible for patients with brain AVMs (ruptured or unruptured) in terms of long-term outcomes, despite the presence of uncertainty. Management may include interventional therapy (neurosurgery, or radiosurgery, alone or in combination, with or without endovascular procedures, alone or combined) or conservative management. An expert multidisciplinary study group will review patients on an individual basis to determine eligibility for the trial or registry parts of the study. The trial has been designed to test whether conservative management or interventional therapy will reduce the risk of disabling stroke or death.

Secondary objectives: To determine if interventional management is effective in the prevention of neurological events during 10 years. To determine the morbidity and mortality related to therapy. To follow-up and record the neurological events and the neurological status of all patients with brain AVMs recruited and managed in our institutions, regardless of management strategy chosen.

Hypotheses

A) Randomized comparison of interventional treatment and conservative management:

Primary hypothesis: Treatment of cerebral AVMs can decrease the number of disabling neurological events caused by the presence of the AVM (excluding peri-operative complications) from 30 to 15% within 10 years. (n = 266 minima) Secondary hypothesis: Treatment of cerebral AVMs can be accomplished with an acceptable up-front risk, defined as the occurrence of a permanent disabling neurological complication in less than 15% of patients)

B) Nested trial on the Role of embolization in the treatment of Brain AVMs by other means Primary hypothesis: Pre-surgical or pre-radiosurgery embolization of cerebral AVMs can decrease the number of treatment failures (failure to achieve angiographic cure) from 20% to 10% (n= 440).

Secondary hypothesis: Embolization of cerebral AVMs can be accomplished with an acceptable risk, defined as permanent disabling neurological complications of 8% (3.4 to 12.6%, 95% C.I.).

The study design is a prospective, multi-center, randomized, controlled trial and registry. Treatment assignment will not be masked; Interim study results will be kept confidential. The primary outcome is the composite event of death from any cause or disabling stroke (hemorrhage or infarction revealed by imaging and resulting in mRS >2). Functional outcome status will be measured by the Rankin Scale, a widely used outcome measure for stroke. The secondary measures of outcome include adverse events, ruptures, and angiographic occlusion of the lesion.

Study Design

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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

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures :

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 :

occurrence of any neurological event [ Time Frame: within 10 years following treatment (or after randomization) ]
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

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:	5 Years and older (Child, 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.

Contacts and Locations

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

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

Locations

Show 29 study locations

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United States, Florida
Mayo Clinic in Jacksonville FL	Recruiting
Jacksonville, Florida, United States
Contact: Rabih Tawk, MD Rabih.tawk@mayo.edu
United States, Massachusetts
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Thanh Nguyen, MD Thanh.Nguyen@bmc.org
United States, New Mexico
University of New Mexico Health Sciences Center	Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Andrew Carlson, MD AndrewCarlson@salud.unm.edu
Brazil
Hospital Geral de Fortaleza	Recruiting
Fortaleza, Brazil
Contact: Iuri Martins, MD iurimartinsb@gmail.com
Principal Investigator: George Nunes Mendes, MD
Universidade Federal de Sǎo Paulo	Recruiting
São Paulo, Brazil
Contact: Luciana Alves Oliveira Silva, MD lucianaalvesmed@gmail.com
Principal Investigator: Gisele Sampaio, MD
Canada, Alberta
University of Alberta Hospital	Recruiting
Edmonton, Alberta, Canada
Contact: Tim Darsaut, MD, PhD tdarsaut@ualberta.ca
Principal Investigator: Tim Darsaut, MD, PhD
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
Chile
Instituto de Neurocirugia Dr. A. Asenjo	Recruiting
Santiago, Chile
Contact: Rodrigo Rivera Miranda, MD rodrigorivera@me.com
Principal Investigator: Rodrigo Rivera Miranda, 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
CHU Clermont-Ferrand	Recruiting
Clermont-Ferrand, France
Contact: Emmanuel Chabert, MD echabert@chu-clermontferrand.fr
CHU Dijon Bourgogne	Recruiting
Dijon, France
Contact: Frédéric Ricolfi, MD frederic.ricolfi@chu-dijon.fr
Hôpital Bicêtre AP-HP	Recruiting
Le Kremlin-Bicêtre, France, 94270
Contact: Laurent Spelle, MD laurent@spelle.fr
CHU Limoges	Recruiting
Limoges, France, 87042
Contact: Charble Mounayer, MD charbel.mounayer@chu-limoges.fr
Centre Hospitalier Universitaire de Lyon	Recruiting
Lyon, France, 69002
Contact: Isabelle Pelissou-Guyotat, MD isabelle.pelissou-guyotat@chu-lyon.fr
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

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Principal Investigator:	Jean Raymond, MD	CHUM-Montreal

More Information

Publications:

Fleetwood IG, Steinberg GK. Arteriovenous malformations. Lancet. 2002 Mar 9;359(9309):863-73. doi: 10.1016/S0140-6736(02)07946-1.

Wedderburn CJ, van Beijnum J, Bhattacharya JJ, Counsell CE, Papanastassiou V, Ritchie V, Roberts RC, Sellar RJ, Warlow CP, Al-Shahi Salman R; SIVMS Collaborators. Outcome after interventional or conservative management of unruptured brain arteriovenous malformations: a prospective, population-based cohort study. Lancet Neurol. 2008 Mar;7(3):223-30. doi: 10.1016/S1474-4422(08)70026-7. Epub 2008 Feb 1.

Brown RD Jr, Wiebers DO, Torner JC, O'Fallon WM. Frequency of intracranial hemorrhage as a presenting symptom and subtype analysis: a population-based study of intracranial vascular malformations in Olmsted Country, Minnesota. J Neurosurg. 1996 Jul;85(1):29-32. doi: 10.3171/jns.1996.85.1.0029.

Brown RD Jr, Wiebers DO, Forbes G, O'Fallon WM, Piepgras DG, Marsh WR, Maciunas RJ. The natural history of unruptured intracranial arteriovenous malformations. J Neurosurg. 1988 Mar;68(3):352-7. doi: 10.3171/jns.1988.68.3.0352.

Wilkins RH. Natural history of intracranial vascular malformations: a review. Neurosurgery. 1985 Mar;16(3):421-30. doi: 10.1227/00006123-198503000-00026.

da Costa L, Wallace MC, Ter Brugge KG, O'Kelly C, Willinsky RA, Tymianski M. The natural history and predictive features of hemorrhage from brain arteriovenous malformations. Stroke. 2009 Jan;40(1):100-5. doi: 10.1161/STROKEAHA.108.524678. Epub 2008 Nov 13.

Gross BA, Du R. Natural history of cerebral arteriovenous malformations: a meta-analysis. J Neurosurg. 2013 Feb;118(2):437-43. doi: 10.3171/2012.10.JNS121280. Epub 2012 Nov 30.

Hernesniemi JA, Dashti R, Juvela S, Vaart K, Niemela M, Laakso A. Natural history of brain arteriovenous malformations: a long-term follow-up study of risk of hemorrhage in 238 patients. Neurosurgery. 2008 Nov;63(5):823-9; discussion 829-31. doi: 10.1227/01.NEU.0000330401.82582.5E.

Hartmann A, Mast H, Mohr JP, Koennecke HC, Osipov A, Pile-Spellman J, Duong DH, Young WL. Morbidity of intracranial hemorrhage in patients with cerebral arteriovenous malformation. Stroke. 1998 May;29(5):931-4. doi: 10.1161/01.str.29.5.931.

Hartmann A, Mast H, Mohr JP, Pile-Spellman J, Connolly ES, Sciacca RR, Khaw A, Stapf C. Determinants of staged endovascular and surgical treatment outcome of brain arteriovenous malformations. Stroke. 2005 Nov;36(11):2431-5. doi: 10.1161/01.STR.0000185723.98111.75. Epub 2005 Oct 13.

Hartmann A, Stapf C, Hofmeister C, Mohr JP, Sciacca RR, Stein BM, Faulstich A, Mast H. Determinants of neurological outcome after surgery for brain arteriovenous malformation. Stroke. 2000 Oct;31(10):2361-4. doi: 10.1161/01.str.31.10.2361.

Cockroft KM, Chang KE, Lehman EB, Harbaugh RE. AVM Management Equipoise Survey: physician opinions regarding the management of brain arteriovenous malformations. J Neurointerv Surg. 2014 Dec;6(10):748-53. doi: 10.1136/neurintsurg-2013-011030. Epub 2013 Dec 6.

Cockroft KM. Unruptured brain arteriovenous malformations should be treated conservatively: no. Stroke. 2007 Dec;38(12):3310-1. doi: 10.1161/STROKEAHA.107.504613. Epub 2007 Oct 25. No abstract available.

Stapf C, Mohr JP. Unruptured brain arteriovenous malformations should be treated conservatively: yes. Stroke. 2007 Dec;38(12):3308-9. doi: 10.1161/STROKEAHA.107.504605. Epub 2007 Oct 25. No abstract available.

van Beijnum J, van der Worp HB, Buis DR, Al-Shahi Salman R, Kappelle LJ, Rinkel GJ, van der Sprenkel JW, Vandertop WP, Algra A, Klijn CJ. Treatment of brain arteriovenous malformations: a systematic review and meta-analysis. JAMA. 2011 Nov 9;306(18):2011-9. doi: 10.1001/jama.2011.1632.

Davies JM, Yanamadala V, Lawton MT. Comparative effectiveness of treatments for cerebral arteriovenous malformations: trends in nationwide outcomes from 2000 to 2009. Neurosurg Focus. 2012 Jul;33(1):E11. doi: 10.3171/2012.5.FOCUS12107.

Morgan MK, Davidson AS, Koustais S, Simons M, Ritson EA. The failure of preoperative ethylene-vinyl alcohol copolymer embolization to improve outcomes in arteriovenous malformation management: case series. J Neurosurg. 2013 May;118(5):969-77. doi: 10.3171/2012.11.JNS112064. Epub 2013 Jan 25.

Pierot L, Fiehler J, Cognard C, Soderman M, Spelle L. Will a randomized trial of unruptured brain arteriovenous malformations change our clinical practice? AJNR Am J Neuroradiol. 2014 Mar;35(3):416-7. doi: 10.3174/ajnr.A3867. Epub 2014 Jan 16. No abstract available.

Raymond J; TEAM collaborative group. Reflections on the TEAM trial: why clinical care and research should be reconciled. Can J Neurol Sci. 2011 Mar;38(2):198-202. doi: 10.1017/s0317167100011343.

Saatci I, Geyik S, Yavuz K, Cekirge HS. Endovascular treatment of brain arteriovenous malformations with prolonged intranidal Onyx injection technique: long-term results in 350 consecutive patients with completed endovascular treatment course. J Neurosurg. 2011 Jul;115(1):78-88. doi: 10.3171/2011.2.JNS09830. Epub 2011 Apr 8.

Spetzler RF, Martin NA. A proposed grading system for arteriovenous malformations. J Neurosurg. 1986 Oct;65(4):476-83. doi: 10.3171/jns.1986.65.4.0476.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Darsaut TE, Magro E, Bojanowski MW, Chaalala C, Nico L, Bacchus E, Klink R, Iancu D, Weill A, Roy D, Sabatier JF, Cognard C, Januel AC, Pelissou-Guyotat I, Eker O, Roche PH, Graillon T, Brunel H, Proust F, Beaujeux R, Aldea S, Piotin M, Cornu P, Shotar E, Gaberel T, Barbier C, Corre ML, Costalat V, Jecko V, Barreau X, Morandi X, Gauvrit JY, Derrey S, Papagiannaki C, Nguyen TN, Abdalkader M, Tawk RG, Huynh T, Viard G, Gevry G, Gentric JC, Raymond J; TOBAS Collaborative Group; List of participating TOBAS centers and physicians. Surgical treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial. J Neurosurg. 2022 Sep 9;138(4):891-899. doi: 10.3171/2022.7.JNS22813. Print 2023 Apr 1.

Magro E, Gentric JC, Batista AL, Kotowski M, Chaalala C, Roberge D, Weill A, Stapf C, Roy D, Bojanowski MW, Darsaut TE, Klink R, Raymond J. The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research. J Neurosurg. 2018 Jun;128(6):1823-1829. doi: 10.3171/2017.2.JNS162751. Epub 2017 Sep 1.

Magro E, Gentric JC, Darsaut TE, Batista AL, Chaalala C, Roberge D, Weill A, Roy D, Bojanowski MW, Raymond J. [Treatment of brain AVMS (TOBAS): A randomized controlled trial and registry]. Neurochirurgie. 2016 Aug;62(4):197-202. doi: 10.1016/j.neuchi.2015.12.008. Epub 2016 May 25. French.

Darsaut TE, Magro E, Gentric JC, Batista AL, Chaalala C, Roberge D, Bojanowski MW, Weill A, Roy D, Raymond J. Treatment of Brain AVMs (TOBAS): study protocol for a pragmatic randomized controlled trial. Trials. 2015 Nov 4;16:497. doi: 10.1186/s13063-015-1019-0.

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Responsible Party:	Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier:	NCT02098252
Other Study ID Numbers:	13.315
First Posted:	March 27, 2014 Key Record Dates
Last Update Posted:	June 10, 2022
Last Verified:	July 2021

Keywords provided by Centre hospitalier de l'Université de Montréal (CHUM):


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

Additional relevant MeSH terms:

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Hemangioma Arteriovenous Malformations Congenital Abnormalities Vascular Malformations Cardiovascular Abnormalities	Cardiovascular Diseases Vascular Diseases Neoplasms, Vascular Tissue Neoplasms by Histologic Type Neoplasms

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