search
Back to results

Treatment of Brain AVMs (TOBAS) Study (TOBAS)

Primary Purpose

Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation, Arteriovenous Malformations

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Neurosurgery
Radiation therapy
Embolization
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unruptured Brain Arteriovenous Malformation focused on measuring brain arteriovenous malformation, Arteriovenous Malformations, AVM, BAVM, Stroke, Intracranial Hemorrhage, Congenital Abnormalities, Aneurysm, Vascular Malformations, Cardiovascular Abnormalities, Cardiovascular Diseases, Vascular Diseases

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic in Jacksonville FLRecruiting
  • Boston Medical CenterRecruiting
  • University of New Mexico Health Sciences CenterRecruiting
  • Hospital Geral de FortalezaRecruiting
  • Universidade Federal de Sǎo PauloRecruiting
  • University of Alberta HospitalRecruiting
  • Klink, RubyRecruiting
  • Instituto de Neurocirugia Dr. A. AsenjoRecruiting
  • Universidad Autonoma de BucaramangaRecruiting
  • CHRU de Brest (Brest University Hospital)Recruiting
  • Centre Hospit Régional Universitaire de BesançonRecruiting
  • Centre Hospitalier Universitaire de BordeauxRecruiting
  • Centre Hospitalier Universitaire de CaenRecruiting
  • CHU Clermont-FerrandRecruiting
  • CHU Dijon BourgogneRecruiting
  • Hôpital Bicêtre AP-HPRecruiting
  • CHU LimogesRecruiting
  • Centre Hospitalier Universitaire de LyonRecruiting
  • Assistance Publique - Hôpitaux de MarseilleRecruiting
  • Centre Hospitalier Universitaire de MontpellierRecruiting
  • Centre Hospitalier Régional Universitaire de NancyRecruiting
  • Centre Hospitalier Universitaire de NantesRecruiting
  • Hôpital Universitaire Pitié-SalpêtrièreRecruiting
  • Fondation Ophtalmologique RothschildRecruiting
  • Centre Hospitalier Sainte-AnneRecruiting
  • Centre Hospitalier Universitaire de RennesRecruiting
  • Centre Hospitalier Universitaire Hôpitaux de RouenRecruiting
  • Les Hôpitaux Universitaires de StrasbourgRecruiting
  • Centre Hospitalier Universitaire de ToulouseRecruiting
  • Centre Hospitalier Régional Universitaire de ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Interventional therapy

Conservative management (medical management)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

composite event of death from any cause or disabling stroke
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
Permanent disabling peri-operative complications
The incidence of permanent (more than 3 months) disabling (mRS >2) peri-operative (within 31 days) complications

Full Information

First Posted
March 25, 2014
Last Updated
July 4, 2023
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre Hospitalier Régional et Universitaire de Brest
search

1. Study Identification

Unique Protocol Identification Number
NCT02098252
Brief Title
Treatment of Brain AVMs (TOBAS) Study
Acronym
TOBAS
Official Title
Treatment of Brain AVMs (TOBAS) Study: A Randomized Controlled Trial and Registry
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2035 (Anticipated)
Study Completion Date
January 2036 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators
Centre Hospitalier Régional et Universitaire de Brest

4. Oversight

Data Monitoring Committee
No

5. 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%.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unruptured Brain Arteriovenous Malformation, Ruptured Brain Arteriovenous Malformation, Arteriovenous Malformations, AVM, BAVM
Keywords
brain arteriovenous malformation, Arteriovenous Malformations, AVM, BAVM, Stroke, Intracranial Hemorrhage, Congenital Abnormalities, Aneurysm, Vascular Malformations, Cardiovascular Abnormalities, Cardiovascular Diseases, Vascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional therapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Conservative management (medical management)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Neurosurgery
Intervention Description
Surgical resection to be used when the lesion is considered by a multidisciplinary team to be safely 'operable'.
Intervention Type
Radiation
Intervention Name(s)
Radiation therapy
Intervention Description
when the AVM is smaller than 3 cm, and considered to not be safely 'operable'.
Intervention Type
Procedure
Intervention Name(s)
Embolization
Intervention Description
Curative embolization, when the lesion is considered curable by embolization.
Primary Outcome Measure Information:
Title
composite event of death from any cause or disabling stroke
Description
death or disabling stroke due to hemorrhage or infarction as revealed by imaging and resulting in mRS >2.
Time Frame
up to 10 years post-treatment (or randomization)
Secondary Outcome Measure Information:
Title
occurrence of any neurological event
Time Frame
within 10 years following treatment (or after randomization)
Title
Permanent disabling peri-operative complications
Description
The incidence of permanent (more than 3 months) disabling (mRS >2) peri-operative (within 31 days) complications
Time Frame
within 31 days post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Daniel Roy, MD
Phone
514-890-8000
Ext
27235
Email
daniel.roy.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Tim Darsaut, MD
Phone
780-407-1440
Email
tdarsaut@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Roy, MD
Organizational Affiliation
CHUM-Montreal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Jacksonville FL
City
Jacksonville
State/Province
Florida
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rabih Tawk, MD
Email
Rabih.tawk@mayo.edu
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thanh Nguyen, MD
Email
Thanh.Nguyen@bmc.org
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Carlson, MD
Email
AndrewCarlson@salud.unm.edu
Facility Name
Hospital Geral de Fortaleza
City
Fortaleza
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iuri Martins, MD
Email
iurimartinsb@gmail.com
First Name & Middle Initial & Last Name & Degree
George Nunes Mendes, MD
Facility Name
Universidade Federal de Sǎo Paulo
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana Alves Oliveira Silva, MD
Email
lucianaalvesmed@gmail.com
First Name & Middle Initial & Last Name & Degree
Gisele Sampaio, MD
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tim Darsaut, MD, PhD
Email
tdarsaut@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Tim Darsaut, MD, PhD
Facility Name
Klink, Ruby
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruby Klink, PhD
Phone
5148908000
Ext
27235
Email
ruby.klink.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Ruby Klink, PhD
Phone
514-890-8000
Ext
27235
Email
ruby.klink.chum@ssss.gouv.qc.ca
First Name & Middle Initial & Last Name & Degree
Daniel Roy, MD
First Name & Middle Initial & Last Name & Degree
Alain Weill, MD
First Name & Middle Initial & Last Name & Degree
Michel Bojanowski, MD
First Name & Middle Initial & Last Name & Degree
Chiraz Chaalala, MD
First Name & Middle Initial & Last Name & Degree
Jean-Paul Bahary, MD
First Name & Middle Initial & Last Name & Degree
David Roberge, MD
First Name & Middle Initial & Last Name & Degree
Laura Masucci, MD
First Name & Middle Initial & Last Name & Degree
Cynthia Ménard, MD
First Name & Middle Initial & Last Name & Degree
Christian Stapf, MD
Facility Name
Instituto de Neurocirugia Dr. A. Asenjo
City
Santiago
Country
Chile
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Rivera Miranda, MD
Email
rodrigorivera@me.com
First Name & Middle Initial & Last Name & Degree
Rodrigo Rivera Miranda, MD
Facility Name
Universidad Autonoma de Bucaramanga
City
Bucaramanga
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Eduardo Mantilla Garcia, MD
Email
dmantilla528@unab.edu.co
First Name & Middle Initial & Last Name & Degree
Andres Felipe Ortiz Giraldo, MD
Email
aortiz131@unab.edu.co
Facility Name
CHRU de Brest (Brest University Hospital)
City
Brest
State/Province
Bretagne
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elsa Magro, MD
Email
elsa.magro@chu-brest.fr
First Name & Middle Initial & Last Name & Degree
Elsa Magro, MD
First Name & Middle Initial & Last Name & Degree
Jean-Christophe Gentric, MD
Facility Name
Centre Hospit Régional Universitaire de Besançon
City
Besançon
ZIP/Postal Code
25030
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessandra Biondi, MD
Email
biondi.alessandra@gmail.com
Facility Name
Centre Hospitalier Universitaire de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Barreau, MD
Email
xavier.barreau@chu-bordeaux.fr
Facility Name
Centre Hospitalier Universitaire de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Courtheoux, MD
Email
courtheoux-p@chu-caen.fr
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel Chabert, MD
Email
echabert@chu-clermontferrand.fr
Facility Name
CHU Dijon Bourgogne
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Ricolfi, MD
Email
frederic.ricolfi@chu-dijon.fr
Facility Name
Hôpital Bicêtre AP-HP
City
Le Kremlin-Bicêtre
ZIP/Postal Code
94270
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent Spelle, MD
Email
laurent@spelle.fr
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charble Mounayer, MD
Email
charbel.mounayer@chu-limoges.fr
Facility Name
Centre Hospitalier Universitaire de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle Pelissou-Guyotat, MD
Email
isabelle.pelissou-guyotat@chu-lyon.fr
Facility Name
Assistance Publique - Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Hugues Roche, MD
Email
pierre-hugues.roche@ap-hm.fr
Facility Name
Centre Hospitalier Universitaire de Montpellier
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Costalat, MD
Email
vincentcost@hotmail.com
Facility Name
Centre Hospitalier Régional Universitaire de Nancy
City
Nancy
ZIP/Postal Code
54035
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Serge Bracard, MD
Email
s.bracard@chru-nancy.fr
Facility Name
Centre Hospitalier Universitaire de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert Desal, MD
Email
hubert.desal@chu-nantes.fr
Facility Name
Hôpital Universitaire Pitié-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Cornu, MD
Email
philippe.cornu@psl.aphp.fr
Facility Name
Fondation Ophtalmologique Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Piotin, MD
Email
mpiotin@for.paris
Facility Name
Centre Hospitalier Sainte-Anne
City
Paris
ZIP/Postal Code
75674
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Trystram, MD
Email
D.TRYSTRAM@ch-sainte-anne.fr
Facility Name
Centre Hospitalier Universitaire de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Morandi, MD
Email
xavier.morandi@chu-rennes.fr
Facility Name
Centre Hospitalier Universitaire Hôpitaux de Rouen
City
Rouen
ZIP/Postal Code
76130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Papagiannaki, MD
Email
c.papagiannaki@chu-rouen.fr
Facility Name
Les Hôpitaux Universitaires de Strasbourg
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
François Proust, MD
Email
francois.proust@neurochirurgie.fr
Facility Name
Centre Hospitalier Universitaire de Toulouse
City
Toulouse
ZIP/Postal Code
70034
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Cognard, MD
Email
cognard.c@chu-toulouse.fr
Facility Name
Centre Hospitalier Régional Universitaire de Tours
City
Tours
ZIP/Postal Code
37000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Herbreteau, MD
Email
denis.herbreteau@univ-tours.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
11897302
Citation
Fleetwood IG, Steinberg GK. Arteriovenous malformations. Lancet. 2002 Mar 9;359(9309):863-73. doi: 10.1016/S0140-6736(02)07946-1.
Results Reference
background
PubMed Identifier
18243054
Citation
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.
Results Reference
background
PubMed Identifier
8683279
Citation
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.
Results Reference
background
PubMed Identifier
3343606
Citation
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.
Results Reference
background
PubMed Identifier
3885072
Citation
Wilkins RH. Natural history of intracranial vascular malformations: a review. Neurosurgery. 1985 Mar;16(3):421-30. doi: 10.1227/00006123-198503000-00026.
Results Reference
background
PubMed Identifier
19008469
Citation
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.
Results Reference
background
PubMed Identifier
23198804
Citation
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.
Results Reference
background
PubMed Identifier
19005371
Citation
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.
Results Reference
background
PubMed Identifier
9596237
Citation
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.
Results Reference
background
PubMed Identifier
16224095
Citation
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.
Results Reference
background
PubMed Identifier
11022064
Citation
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.
Results Reference
background
PubMed Identifier
24319022
Citation
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.
Results Reference
background
PubMed Identifier
17962584
Citation
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.
Results Reference
background
PubMed Identifier
17962585
Citation
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.
Results Reference
background
PubMed Identifier
22068993
Citation
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.
Results Reference
background
PubMed Identifier
22746228
Citation
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.
Results Reference
background
PubMed Identifier
23350776
Citation
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.
Results Reference
background
PubMed Identifier
24436345
Citation
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.
Results Reference
background
PubMed Identifier
21320821
Citation
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.
Results Reference
background
PubMed Identifier
21476804
Citation
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.
Results Reference
background
PubMed Identifier
3760956
Citation
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.
Results Reference
background
PubMed Identifier
36087316
Citation
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.
Results Reference
derived
PubMed Identifier
28862547
Citation
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.
Results Reference
derived
PubMed Identifier
27236732
Citation
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.
Results Reference
derived
PubMed Identifier
26530856
Citation
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.
Results Reference
derived

Learn more about this trial

Treatment of Brain AVMs (TOBAS) Study

We'll reach out to this number within 24 hrs