Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
NA
Total Enrollment
1000 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-05-31
Study Completion Date
2036-01-31
Brief Summary
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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%.
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%.
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Detailed Description
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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.
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.
Conditions
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Unruptured Brain Arteriovenous Malformation
Ruptured Brain Arteriovenous Malformation
Arteriovenous Malformations
AVM
BAVM
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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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.
Group Type
ACTIVE_COMPARATOR
Neurosurgery
Intervention Type
PROCEDURE
Surgical resection to be used when the lesion is considered by a multidisciplinary team to be safely 'operable'.
Radiation therapy
Intervention Type
RADIATION
when the AVM is smaller than 3 cm, and considered to not be safely 'operable'.
Embolization
Intervention Type
PROCEDURE
Curative embolization, when the lesion is considered curable by embolization.
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.
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
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Neurosurgery
Surgical resection to be used when the lesion is considered by a multidisciplinary team to be safely 'operable'.
Intervention Type
PROCEDURE
Radiation therapy
when the AVM is smaller than 3 cm, and considered to not be safely 'operable'.
Intervention Type
RADIATION
Embolization
Curative embolization, when the lesion is considered curable by embolization.
Intervention Type
PROCEDURE
Eligibility Criteria
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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.
Minimum Eligible Age
5 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Centre Hospitalier Régional et Universitaire de Brest
OTHER
Sponsor Role
collaborator
Centre hospitalier de l'Université de Montréal (CHUM)
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Daniel Roy, MD
Role: PRINCIPAL_INVESTIGATOR
CHUM-Montreal
Locations
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Mayo Clinic in Jacksonville FL
Jacksonville, Florida, United States
Site Status
RECRUITING
Boston Medical Center
Boston, Massachusetts, United States
Site Status
RECRUITING
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States
Site Status
RECRUITING
Hospital Geral de Fortaleza
Fortaleza, , Brazil
Site Status
RECRUITING
Universidade Federal de Sǎo Paulo
São Paulo, , Brazil
Site Status
RECRUITING
University of Alberta Hospital
Edmonton, Alberta, Canada
Site Status
RECRUITING
Klink, Ruby
Montreal, Quebec, Canada
Site Status
RECRUITING
Instituto de Neurocirugia Dr. A. Asenjo
Santiago, , Chile
Site Status
RECRUITING
Universidad Autonoma de Bucaramanga
Bucaramanga, , Colombia
Site Status
RECRUITING
CHRU de Brest (Brest University Hospital)
Brest, Brittany Region, France
Site Status
RECRUITING
Centre Hospit Régional Universitaire de Besançon
Besançon, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Caen
Caen, , France
Site Status
RECRUITING
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Site Status
RECRUITING
CHU Dijon Bourgogne
Dijon, , France
Site Status
RECRUITING
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, , France
Site Status
RECRUITING
CHU Limoges
Limoges, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Lyon
Lyon, , France
Site Status
RECRUITING
Assistance Publique - Hôpitaux de Marseille
Marseille, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Site Status
RECRUITING
Centre Hospitalier Régional Universitaire de Nancy
Nancy, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Nantes
Nantes, , France
Site Status
RECRUITING
Hôpital Universitaire Pitié-Salpêtrière
Paris, , France
Site Status
RECRUITING
Fondation Ophtalmologique Rothschild
Paris, , France
Site Status
RECRUITING
Centre Hospitalier Sainte-Anne
Paris, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Rennes
Rennes, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire Hôpitaux de Rouen
Rouen, , France
Site Status
RECRUITING
Les Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Site Status
RECRUITING
Centre Hospitalier Universitaire de Toulouse
Toulouse, , France
Site Status
RECRUITING
Centre Hospitalier Régional Universitaire de Tours
Tours, , France
Site Status
RECRUITING
Countries
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United States
Brazil
Canada
Chile
Colombia
France
Central Contacts
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Facility Contacts
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References
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Fleetwood IG, Steinberg GK. Arteriovenous malformations. Lancet. 2002 Mar 9;359(9309):863-73. doi: 10.1016/S0140-6736(02)07946-1.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Wilkins RH. Natural history of intracranial vascular malformations: a review. Neurosurgery. 1985 Mar;16(3):421-30. doi: 10.1227/00006123-198503000-00026.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
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.
Reference Type
BACKGROUND
Raymond J, Gentric JC, Magro E, Nico L, Bacchus E, Klink R, Cognard C, Januel AC, Sabatier JF, Iancu D, Weill A, Roy D, Bojanowski MW, Chaalala C, Barreau X, Jecko V, Papagiannaki C, Derrey S, Shotar E, Cornu P, Eker OF, Pelissou-Guyotat I, Piotin M, Aldea S, Beaujeux R, Proust F, Anxionnat R, Costalat V, Corre ML, Gauvrit JY, Morandi X, Brunel H, Roche PH, Graillon T, Chabert E, Herbreteau D, Desal H, Trystram D, Barbier C, Gaberel T, Nguyen TN, Viard G, Gevry G, Darsaut TE; TOBAS Collaborative Group; Collaborators in the TOBAS Collaborative Group. Endovascular treatment of brain arteriovenous malformations: clinical outcomes of patients included in the registry of a pragmatic randomized trial. J Neurosurg. 2022 Oct 28;138(5):1393-1402. doi: 10.3171/2022.9.JNS22987. Print 2023 May 1.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
13.315
Identifier Type: -
Identifier Source: org_study_id
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