Study Results
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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COMPLETED
PHASE3
226 participants
INTERVENTIONAL
2006-10-31
2015-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medical management
Patients with unruptured BAVMs will receive symptomatic medical management alone.
Medical management
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.
Interventional therapy
Patients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy).
Interventional therapy
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 management
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.
Interventions
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Interventional therapy
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 management
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.
Eligibility Criteria
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Inclusion Criteria
2. Patient must be 18 years of age or older
3. Patient must have signed Informed Consent, Release of Medical Information, and Health Insurance Portability and Accountability Act (HIPAA/U.S. only) Forms
Exclusion Criteria
2. Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy)
3. 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)
4. Patient has baseline Rankin ≥2
5. Patient has concomitant disease reducing life expectancy to less than 10 years
6. Patient has thrombocytopenia (\< 100,000/μL),
7. Patient has uncorrectable coagulopathy (INR\>1.5)
8. Patient is pregnant or lactating
9. Patient has known allergy against iodine contrast agents
10. Patient has multiple-foci BAVMs
11. Patient has any form of arteriovenous or spinal fistulas
Previous diagnosis of any of the following -
12. Patient has a diagnosed Vein of Galen type malformation
13. Patient has a diagnosed cavernous malformation
14. Patient has a diagnosed dural arteriovenous fistula
15. Patient has a diagnosed venous malformation
16. Patient has a diagnosed neurocutaneous syndrome such as cerebro-retinal angiomatosis (von Hippel-Lindau), encephalo-trigeminal syndrome (Sturge-Weber), or Wyburn-Mason syndrome
17. Patient has diagnosed BAVMs in context of moya-moya-type changes
18. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Columbia University
OTHER
Responsible Party
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Jay Preston Mohr
Daniel Sciarra Professor of Neurology
Principal Investigators
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J.P. Mohr, MS, MD
Role: PRINCIPAL_INVESTIGATOR
Stroke Center/The Neurological Institute, Columbia University
Alan J. Moskowitz, MD
Role: PRINCIPAL_INVESTIGATOR
InCHOIR, Department of Health Policy, Mount Sinai School of Medicine
Michael Parides, PhD
Role: PRINCIPAL_INVESTIGATOR
InCHOIR, Department of Health Policy, Mount Sinai School of Medicine, Co-PI
Christian Stapf, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Coordinating Center, Europe
Eric Vicaut, MD
Role: PRINCIPAL_INVESTIGATOR
Clinical Coordinating Center, Europe, Co-PI
Claudia S. Moy, PhD
Role: PRINCIPAL_INVESTIGATOR
NINDS, Co-PI
Locations
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Barrow Neurological Institute, 350 West Thomas Road
Phoenix, Arizona, United States
Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd
Los Angeles, California, United States
University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza
Los Angeles, California, United States
Kaiser Permanente (SF)
Redwood City, California, United States
University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38
San Francisco, California, United States
University of Miami
Miami, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700
Maywood, Illinois, United States
University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive ,
Iowa City, Iowa, United States
Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road
Southfield, Michigan, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, United States
SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189
Brooklyn, New York, United States
Mercy Hospital of Buffalo
Buffalo, New York, United States
Winthrop University Hospital
Mineola, New York, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136
New York, New York, United States
New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St
New York, New York, United States
John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120,
Johnstown, Pennsylvania, United States
Thomas Jefferson Hospital for Neuroscience
Philadelphia, Pennsylvania, United States
Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street
Austin, Texas, United States
University of Texas Medical School in Houston
Houston, Texas, United States
University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212
Charlottesville, Virginia, United States
Sentara Medical Group
Norfolk, Virginia, United States
Marshfield Clinic
Marshfield, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Wesley Medical Center
Auchenflower, Queensland, Australia
Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights
Melbourne, Victoria, Australia
Universitätsklinik für Neurologie, Anichstrasse 35, 6020 Innsbruck
Innsbruck, , Austria
Rudolfstiftung, Neurochirurgie, Juchgasse 25, A-1030
Vienna, , Austria
Hospital de Clinicas de Porto Alegre
Porto Alegre, , Brazil
Hamilton General Hospital .237 Barton Street East
Hamilton, Ontario, Canada
London Health Sciences Center
London, Ontario, Canada
CHUM Notre Dame Hospital, Department of Radiology, 1560 Sherbrooke Street
Montreal, Quebec, Canada
Helsinki University Central Hospital, Dept. of Neurosurgery, Topeliuksenkatu 5, Helsinki, P.O. Box 266
Helsinki, , Finland
Hôpital de la Cavale-Blanche, Service de Neurologie, Bd. Tanguy Pringent
Brest, , France
CHU Henri Mondor, Service de Neuroradiologie
Créteil, , France
Centre Hospitalier Régional et Universitaire de Lille, Clinique de Neurochirurgie, Hopital Roger Salengro, CHRU
Lille, , France
Hôpital Sainte Anne, Service de Neurochirurgie, Centre Hospitalier Sainte Anne, 1, Rue Cabanis
Paris, , France
Hôpital Lariboisière, Service de Neuroradiologie, 2, Rue Ambroise Paré
Paris, , France
European Coordinating Center: Dept. of Neurology, Hôpital Lariboisière, 2 Rue Ambroise Paré, 75475 Paris cedex 10,
Paris, , France
Charité Campus Benjamin Franklin (CCBF), Neurologische Klinik, Hindenburgdamm 30
Berlin, , Germany
Uniklinikum Dresden, Neuroradiologie, Fetscherstr. 74
Dresden, , Germany
Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Hufelandstraße 55
Essen, , Germany
Uniklinikum Frankfurt, Institut für Neuroradiologie, Schleusenweg 2-16
Frankfurt am Main, , Germany
Uniklinik Freiburg, Neuroradiology-Neurocenter, Breisacher Str. 64
Freiburg im Breisgau, , Germany
Berufsgenossenschaftliche Kliniken Bergmannstrost, Klinik für Neurochirurgie, Merseburger Str. 165
Halle, , Germany
Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52
Hamburg, , Germany
Universitätsklinik Heidelberg, Department of Neurosurgery, Im Neuenheimer Feld 400
Heidelberg, , Germany
Klinikum Großhadern, LMU München, Neurologische Klinik und Poliklinik, Marchionistr. 15
Munich, , Germany
Bellaria Hospital, Department of Neurosurgery
Bologna, , Italy
Servizio di Neuroradiologia, Ospedale San Raffaele, Via Olgettina 60
Milan, , Italy
Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1
Groningen, , Netherlands
Utrecht University Hospital, Heidelberglaan 100, 3584 CX
Utrecht, , Netherlands
Seoul National University Hospital
Seoul, Seoul, South Korea
Hospital Universitari de Bellvitge, Sección de Neuroradiologia, c/ Feixa Llarga s/n, L'Hospitalet de Llobregat
Barcelona, , Spain
Inselspital, Neurologische Klinik, 3010 Bern
Schweiz, , Switzerland
Frenchay Hospital, Neuroradiology Department
Bristol, , United Kingdom
Western General Hospital, Bramwell Dott Building, Department of Clinical Neurosciences, Crewe Road
Edinburgh, , United Kingdom
Consultant Neurologist, Department of Neurology, Leeds General Infirmary, Great George Street
Leeds, , United Kingdom
Walton Centre for Neurology, Lower Lane Fazakerley
Liverpool, , United Kingdom
Institute of Neurology, Box 6, The National Hospital, Queen Square
London, , United Kingdom
Department of Neurosurgery, Newcastle General Hospital, Westgate Road
Newcastle upon Tyne, , United Kingdom
Imaging Directorate, Derriford Hospital
Plymouth, , United Kingdom
Neuroscience Department, Royal Preston Hospital, Sharoe Green Lane, Fulwood
Preston, , United Kingdom
Department of Neurology, Hope Hospital
Salford, , United Kingdom
Department of Neurology, Royal Hallamshire Hospital, Glossop Road
Sheffield, , United Kingdom
Countries
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References
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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.
Mohr 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.
Mohr 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.
Mohr 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.
Stapf 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.
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.
Related Links
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An ARUBA web site has been developed to allow physicians to have access to up-to-date trial information. It will also be available to patients and their families.
Other Identifiers
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