Arteriovenous Malformations, CerebralPhase 3ARUBANCT00389181
A Randomized Trial of Unruptured Brain AVMs
A Phase 3 study testing Interventional therapy and Medical management in people with Arteriovenous Malformations, Cerebral, run by Columbia University at 66 sites in 14 countries.
Trial summary
The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arteriovenous Malformations, Cerebral
- What is being tested?
- Interventional therapy and Medical management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 66 sitesin 14 countries
- Study dates
- Oct 2006to May 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must have unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram
- Patient must be 18 years of age or older
- Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms
Who cannot join
- Patient has BAVM presenting with evidence of recent or prior hemorrhage
- Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)
- Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicates any interventional therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons)
- Patient has baseline Rankin ≥2
- Patient has concomitant disease reducing life expectancy to less than 10 years
- Patient has thrombocytopenia (< 100,000/μL),
Show all 19Show fewer
- Patient has uncorrectable coagulopathy (INR>1.5)
- Patient is pregnant or lactating
- Patient has known allergy against iodine contrast agents
- Patient has multiple-foci BAVMs
- Patient has any form of arteriovenous or spinal fistulas
- Previous diagnosis of any of the following -
- Patient has a diagnosed Vein of Galen type malformation
- Patient has a diagnosed cavernous malformation
- Patient has a diagnosed dural arteriovenous fistula
- Patient has a diagnosed venous malformation
- Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome
- Patient has diagnosed BAVMs in context of moya-moya-type changes
- Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
Trial locations and contacts
66 sites in 14 countries.
66 sites in 14 countries
United States25 sites
Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street
Austin, Texas, 78701
SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189
Brooklyn, New York, 11203-2098
Mercy Hospital of Buffalo
Buffalo, New York, 14220
University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212
Charlottesville, Virginia, 22908
Rush University Medical Center
Chicago, Illinois, 60612
University of Texas Medical School in Houston
Houston, Texas, 77030
University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive ,
Iowa City, Iowa, 52242-1009
John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120,
Johnstown, Pennsylvania, 15904
Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd
Los Angeles, California, 90027
University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza
Los Angeles, California, 90095-1769
Marshfield Clinic
Marshfield, Wisconsin, 54449
Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700
Maywood, Illinois, 60153-3304
University of Miami
Miami, Florida, 33146
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226-4874
Winthrop University Hospital
Mineola, New York, 11501
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136
New York, New York, 10029
New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St
New York, New York, 10032
Sentara Medical Group
Norfolk, Virginia, 23502
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Thomas Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, 19107
Barrow Neurological Institute, 350 West Thomas Road
Phoenix, Arizona, 85013
Kaiser Permanente (SF)
Redwood City, California, 94063
University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38
San Francisco, California, 94110
Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road
Southfield, Michigan, 48075
United Kingdom10 sites
Frenchay Hospital, Neuroradiology Department
Bristol, BS 16 1LE
Western General Hospital, Bramwell Dott Building, Department of Clinical Neurosciences, Crewe Road
Edinburgh, EH4 2XU
Consultant Neurologist, Department of Neurology, Leeds General Infirmary, Great George Street
Leeds, LS1 3EX
Walton Centre for Neurology, Lower Lane Fazakerley
Liverpool, L9 7LJ
Institute of Neurology, Box 6, The National Hospital, Queen Square
London, WC12N 3BG
Department of Neurosurgery, Newcastle General Hospital, Westgate Road
Newcastle upon Tyne, NE4 6BE
Imaging Directorate, Derriford Hospital
Plymouth, PL6 8DH
Neuroscience Department, Royal Preston Hospital, Sharoe Green Lane, Fulwood
Preston, PR2 9HP
Department of Neurology, Hope Hospital
Salford, M6 8HD
Department of Neurology, Royal Hallamshire Hospital, Glossop Road
Sheffield, 810 2JF
Germany9 sites
Charité Campus Benjamin Franklin (CCBF), Neurologische Klinik, Hindenburgdamm 30
Berlin, 12200
Uniklinikum Dresden, Neuroradiologie, Fetscherstr. 74
Dresden, 01307
Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Hufelandstraße 55
Essen, 45147
Uniklinikum Frankfurt, Institut für Neuroradiologie, Schleusenweg 2-16
Frankfurt am Main, 60528
Uniklinik Freiburg, Neuroradiology-Neurocenter, Breisacher Str. 64
Freiburg im Breisgau, 79106
Berufsgenossenschaftliche Kliniken Bergmannstrost, Klinik für Neurochirurgie, Merseburger Str. 165
Halle, 06112
Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52
Hamburg, 20246
Universitätsklinik Heidelberg, Department of Neurosurgery, Im Neuenheimer Feld 400
Heidelberg, 69120
Klinikum Großhadern, LMU München, Neurologische Klinik und Poliklinik, Marchionistr. 15
Munich, 81377
France6 sites
Hôpital de la Cavale-Blanche, Service de Neurologie, Bd. Tanguy Pringent
Brest, 29609
CHU Henri Mondor, Service de Neuroradiologie
Créteil, 94010
Centre Hospitalier Régional et Universitaire de Lille, Clinique de Neurochirurgie, Hopital Roger Salengro, CHRU
Lille, 59037
Hôpital Sainte Anne, Service de Neurochirurgie, Centre Hospitalier Sainte Anne, 1, Rue Cabanis
Paris, 75014
Hôpital Lariboisière, Service de Neuroradiologie, 2, Rue Ambroise Paré
Paris, 75475
European Coordinating Center: Dept. of Neurology, Hôpital Lariboisière, 2 Rue Ambroise Paré, 75475 Paris cedex 10,
Paris
Canada3 sites
Hamilton General Hospital .237 Barton Street East
Hamilton, Ontario, L8L 2X2
London Health Sciences Center
London, Ontario, N6A 5W9
CHUM Notre Dame Hospital, Department of Radiology, 1560 Sherbrooke Street
Montreal, Quebec, H2L 4M1
Australia2 sites
Wesley Medical Center
Auchenflower, Queensland, 4066
Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights
Melbourne, Victoria, 3081
Austria2 sites
Universitätsklinik für Neurologie, Anichstrasse 35, 6020 Innsbruck
Innsbruck
Rudolfstiftung, Neurochirurgie, Juchgasse 25, A-1030
Vienna
Italy2 sites
Bellaria Hospital, Department of Neurosurgery
Bologna, 40139
Servizio di Neuroradiologia, Ospedale San Raffaele, Via Olgettina 60
Milan, 20131
Netherlands2 sites
Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1
Groningen, 9700
Utrecht University Hospital, Heidelberglaan 100, 3584 CX
Utrecht
Finland1 site
Helsinki University Central Hospital, Dept. of Neurosurgery, Topeliuksenkatu 5, Helsinki, P.O. Box 266
Helsinki, FI-00029 HUS
South Korea1 site
Seoul National University Hospital
Seoul, Seoul, 1 10-744
Spain1 site
Hospital Universitari de Bellvitge, Sección de Neuroradiologia, c/ Feixa Llarga s/n, L'Hospitalet de Llobregat
Barcelona, 08907
About this study
Official title: A Randomized Trial of Unruptured Brain Arteriovenous Malformations
The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.
Read the detailed description
Brain arteriovenous malformations (BAVMs) are an infrequent but important cause of stroke, particularly in a young population. Current invasive treatment strategies are varied and include endovascular procedures, neurosurgery, and radiotherapy. All of these treatments are administered on the assumption that they can be achieved at acceptably minor complication rates, decrease the risk of subsequent hemorrhage, and lead to better long-term outcomes.
Recent data from the literature comparing initial presentation and outcome for patients with ruptured and unruptured BAVMs have raised the possibility that such elective invasive treatment for unruptured BAVMs may yield worse outcomes than managing patients symptomatically with therapy. Unfortunately, no controlled clinical trials have yet been undertaken for management of unruptured BAVMs to address these concerns. Therefore, the goal of this randomized controlled trial is to determine if the long-term outcomes of patients who receive medical management for symptoms (e.g., headache, seizures) associated with an unruptured BAVM are superior to those who receive medical management and invasive therapy to eradicate the BAVM.
Participants will be randomly assigned to receive either symptomatic medical management alone or such management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy). Functional assessment will be carried out at the time of randomization, pre-intervention and 48-hour post-intervention, and for all participants at 1 month, and at 6 month intervals throughout the follow up period which will be a minimum of 5 years.
- Conditions
- Arteriovenous Malformations, Cerebral
- Being tested
- Interventional therapy, Medical management
- Keywords
- Unruptured brain arteriovenous malformation, AVM, BAVM, Stroke, Intracranial Hemorrhage
- Medical subject headings
- Intracranial Arteriovenous Malformations, Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventional therapyProcedure or surgery
All interventional procedures are standard of care for the treatment of AVMs. They are not experimental. A patient randomized to interventional therapy is expected to begin interventional therapy within 3 months following randomization. Interventional therapy consists of endovascular attempts at occlusion of the nidus and feeding vessels, coiling or microsurgery for feeding artery aneurysms, microsurgery for BAVM itself, and radiosurgery, these alone or in various combinations and timings.
Medical managementOther
Patients participating in the trial will receive the best medical management possible for the disorder being tested in the trial and for any general medical illnesses they are demonstrated to have. One important consideration in the medical management of patients in this trial is stroke risk factor reduction.
| Study group | Role | What they receive |
|---|---|---|
| Medical management | Experimental | Patients with unruptured BAVMs will receive symptomatic medical management alone. Receives: Other: Medical management |
| Interventional therapy | Active comparator | Patients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy). Receives: Procedure: Interventional therapy; Other: Medical management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of 5-year event rates between two arms
The hypothesis to be tested is that there is no difference between medical management and interventional therapy in the time to stroke or death from any cause.
Measured: 5 years
Secondary outcomes (1)
Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention
The hypothesis to be tested is that early intervention decreases the risk of death or clinical impairment at 5 years post-randomization. (Rankin Score >/= 2)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionJun 2013
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Arteriovenous Malformations, CerebralStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Preston Mohr, Columbia University
- Investigators
- J.P. Mohr, MS, MD, Principal investigator, Stroke Center/The Neurological Institute, Columbia UniversityAlan J. Moskowitz, MD, Principal investigator, InCHOIR, Department of Health Policy, Mount Sinai School of MedicineMichael Parides, PhD, Principal investigator, InCHOIR, Department of Health Policy, Mount Sinai School of Medicine, Co-PIChristian Stapf, MD, Principal investigator, Clinical Coordinating Center, EuropeEric Vicaut, MD, Principal investigator, Clinical Coordinating Center, Europe, Co-PIClaudia S. Moy, PhD, Principal investigator, NINDS, Co-PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389181
- Sponsor's protocol ID
- AAAB6286
- Other IDs
- U01NS051566, U01NS051483
- Acronym
- ARUBA
- Status last verified
- Jun 2015
- First submitted
- 16 Oct 2006
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stapf C, Mohr JP, Choi JH, Hartmann A, Mast H. Invasive treatment of unruptured brain arteriovenous malformations is experimental therapy. Curr Opin Neurol. 2006 Feb;19(1):63-8. doi: 10.1097/01.wco.0000200546.14668.78.
PubMed 16415679Mohr JP, Overbey JR, Hartmann A, Kummer RV, Al-Shahi Salman R, Kim H, van der Worp HB, Parides MK, Stefani MA, Houdart E, Libman R, Pile-Spellman J, Harkness K, Cordonnier C, Moquete E, Biondi A, Klijn CJM, Stapf C, Moskowitz AJ; ARUBA co-investigators. Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial. Lancet Neurol. 2020 Jul;19(7):573-581. doi: 10.1016/S1474-4422(20)30181-2.
PubMed 32562682Mohr JP, Overbey JR, von Kummer R, Stefani MA, Libman R, Stapf C, Parides MK, Pile-Spellman J, Moquete E, Moy CS, Vicaut E, Moskowitz AJ, Harkness K, Cordonnier C, Biondi A, Houdart E, Berkefeld J, Klijn CJM, Barreau X, Kim H, Hartmann A; International ARUBA Investigators. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs. Neurology. 2017 Oct 3;89(14):1499-1506. doi: 10.1212/WNL.0000000000004532. Epub 2017 Sep 6.
PubMed 28878048Mohr JP, Parides MK, Stapf C, Moquete E, Moy CS, Overbey JR, Al-Shahi Salman R, Vicaut E, Young WL, Houdart E, Cordonnier C, Stefani MA, Hartmann A, von Kummer R, Biondi A, Berkefeld J, Klijn CJ, Harkness K, Libman R, Barreau X, Moskowitz AJ; international ARUBA investigators. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet. 2014 Feb 15;383(9917):614-21. doi: 10.1016/S0140-6736(13)62302-8. Epub 2013 Nov 20.
PubMed 24268105Stapf C. The rationale behind "A Randomized Trial of Unruptured Brain AVMs" (ARUBA). Acta Neurochir Suppl. 2010;107:83-5. doi: 10.1007/978-3-211-99373-6_13.
PubMed 19953376Stapf 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.
PubMed 17962585
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Unruptured Brain Arteriovenous Malformations
- ClinicalTrials.gov ID
- NCT00389181
- Acronym / sponsor ID
- ARUBA / AAAB6286
- Conditions
- Arteriovenous Malformations, Cerebral
- Keywords
- Unruptured brain arteriovenous malformation, AVM, BAVM, Stroke, Intracranial Hemorrhage
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- Oct 2006
- Primary completion
- Jun 2013 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 18 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if medical management is better than invasive therapy for improving the long-term outcome of patients with unruptured brain arteriovenous malformations.
Detailed description
Brain arteriovenous malformations (BAVMs) are an infrequent but important cause of stroke, particularly in a young population. Current invasive treatment strategies are varied and include endovascular procedures, neurosurgery, and radiotherapy. All of these treatments are administered on the assumption that they can be achieved at acceptably minor complication rates, decrease the risk of subsequent hemorrhage, and lead to better long-term outcomes.
Recent data from the literature comparing initial presentation and outcome for patients with ruptured and unruptured BAVMs have raised the possibility that such elective invasive treatment for unruptured BAVMs may yield worse outcomes than managing patients symptomatically with therapy. Unfortunately, no controlled clinical trials have yet been undertaken for management of unruptured BAVMs to address these concerns. Therefore, the goal of this randomized controlled trial is to determine if the long-term outcomes of patients who receive medical management for symptoms (e.g., headache, seizures) associated with an unruptured BAVM are superior to those who receive medical management and invasive therapy to eradicate the BAVM.
Participants will be randomly assigned to receive either symptomatic medical management alone or such management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy). Functional assessment will be carried out at the time of randomization, pre-intervention and 48-hour post-intervention, and for all participants at 1 month, and at 6 month intervals throughout the follow up period which will be a minimum of 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical management | Experimental | Other: Medical managementPatients with unruptured BAVMs will receive symptomatic medical management alone. |
| Interventional therapy | Active comparator | Procedure: Interventional therapy, Other: Medical managementPatients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient must have unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram
- Patient must be 18 years of age or older
- Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms
Key exclusion criteria (19 listed)
- Patient has BAVM presenting with evidence of recent or prior hemorrhage
- Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)
- Patient has BAVM deemed untreatable by local team, or has concomitant vascular or brain disease that interferes with/or contraindicates any interventional therapy type (stenosis/occlusion of neck artery, prior brain surgery/radiation for other reasons)
- Patient has baseline Rankin ≥2
- Patient has concomitant disease reducing life expectancy to less than 10 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interventional therapyAll interventional procedures are standard of care for the treatment of AVMs. They are not experimental. A patient randomized to interventional therapy is expected to begin interventional therapy within 3 months following randomization. Interventional therapy consists of endovascular attempts at occlusion of the nidus and feeding vessels, coiling or microsurgery for feeding artery aneurysms, microsurgery for BAVM itself, and radiosurgery, these alone or in various combinations and timings. | Procedure or surgery | Interventional therapy |
| Medical managementPatients participating in the trial will receive the best medical management possible for the disorder being tested in the trial and for any general medical illnesses they are demonstrated to have. One important consideration in the medical management of patients in this trial is stroke risk factor reduction. | Other | Interventional therapy, Medical management |
Primary outcome
Difference of 5-year event rates between two arms
Time frame: 5 years
The hypothesis to be tested is that there is no difference between medical management and interventional therapy in the time to stroke or death from any cause.
1 secondary outcome
Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Background: PubMed 16415679Stapf C, Mohr JP, Choi JH, Hartmann A, Mast H. Invasive treatment of unruptured brain arteriovenous malformations is experimental therapy. Curr Opin Neurol. 2006 Feb;19(1):63-8. doi: 10.1097/01.wco.0000200546.14668.78.
- Derived from this study: PubMed 32562682Mohr JP, Overbey JR, Hartmann A, Kummer RV, Al-Shahi Salman R, Kim H, van der Worp HB, Parides MK, Stefani MA, Houdart E, Libman R, Pile-Spellman J, Harkness K, Cordonnier C, Moquete E, Biondi A, Klijn CJM, Stapf C, Moskowitz AJ; ARUBA co-investigators. Medical management with interventional therapy versus medical management alone for unruptured brain arteriovenous malformations (ARUBA): final follow-up of a multicentre, non-blinded, randomised controlled trial. Lancet Neurol. 2020 Jul;19(7):573-581. doi: 10.1016/S1474-4422(20)30181-2.
- Derived from this study: PubMed 28878048Mohr JP, Overbey JR, von Kummer R, Stefani MA, Libman R, Stapf C, Parides MK, Pile-Spellman J, Moquete E, Moy CS, Vicaut E, Moskowitz AJ, Harkness K, Cordonnier C, Biondi A, Houdart E, Berkefeld J, Klijn CJM, Barreau X, Kim H, Hartmann A; International ARUBA Investigators. Functional impairments for outcomes in a randomized trial of unruptured brain AVMs. Neurology. 2017 Oct 3;89(14):1499-1506. doi: 10.1212/WNL.0000000000004532. Epub 2017 Sep 6.
- Derived from this study: PubMed 24268105Mohr JP, Parides MK, Stapf C, Moquete E, Moy CS, Overbey JR, Al-Shahi Salman R, Vicaut E, Young WL, Houdart E, Cordonnier C, Stefani MA, Hartmann A, von Kummer R, Biondi A, Berkefeld J, Klijn CJ, Harkness K, Libman R, Barreau X, Moskowitz AJ; international ARUBA investigators. Medical management with or without interventional therapy for unruptured brain arteriovenous malformations (ARUBA): a multicentre, non-blinded, randomised trial. Lancet. 2014 Feb 15;383(9917):614-21. doi: 10.1016/S0140-6736(13)62302-8. Epub 2013 Nov 20.
- Derived from this study: PubMed 19953376Stapf C. The rationale behind "A Randomized Trial of Unruptured Brain AVMs" (ARUBA). Acta Neurochir Suppl. 2010;107:83-5. doi: 10.1007/978-3-211-99373-6_13.
- Derived from this study: PubMed 17962585Stapf 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J.P. Mohr, MS, MD principal investigator
Stroke Center/The Neurological Institute, Columbia University
Alan J. Moskowitz, MD principal investigator
InCHOIR, Department of Health Policy, Mount Sinai School of Medicine
Michael Parides, PhD principal investigator
InCHOIR, Department of Health Policy, Mount Sinai School of Medicine, Co-PI
66 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interventional therapy and Medical management in people with Arteriovenous Malformations, Cerebral, run by Columbia University at 66 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, United Kingdom, Germany, France, Canada and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of 5-year event rates between two arms (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00389181, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2015.