A Randomized Trial of Unruptured Brain AVMs "ARUBA"

Completed

Phase 3 Results N/A

Update History

5 Jun '15
The eligibility criteria were updated.
New
Inclusion Criteria: 1. Patient must have unruptured BAVM diagnosed by MRI/MRA, CTA and/or angiogram 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: 1. Patient has BAVM presenting with evidence of recent or prior hemorrhage 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)
Old
Inclusion Criteria: - Patient must have unruptured BAVM diagnosed by MRI/MRA and/or angiogram - Patient must be 18 years of age or older Exclusion Criteria: - Patient has evidence of recent or prior BAVM hemorrhage - Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy) - Patient has BAVM deemed untreatable by local investigator, or has concomitant vascular or brain disease that interferes with/or contradicts any invasive 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/nl) or coagulopathy (spontaneous or iatrogenic INR>1.5) - Patient is pregnant or lactating - Patient has known allergy against iodine contrast agents, multiple-foci BAVMs, or any form of arteriovenous or spinal fistulas - Patient has a diagnosed Vein of Galen type malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or 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, or hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
24 Apr '13
A location was updated in Phoenix.
New
The overall status was removed for Barrow Neurological Institute, 350 West Thomas Road.
A location was updated in Los Angeles.
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The overall status was removed for University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza.
A location was updated in Los Angeles.
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The overall status was removed for Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd.
A location was updated in Redwood City.
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The overall status was removed for Kaiser Permanente (SF).
A location was updated in San Francisco.
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The overall status was removed for University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38.
A location was updated in Miami.
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The overall status was removed for University of Miami.
A location was updated in Chicago.
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The overall status was removed for Rush University Medical Center.
A location was updated in Maywood.
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The overall status was removed for Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700.
A location was updated in Iowa City.
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The overall status was removed for University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive ,.
A location was updated in Southfield.
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The overall status was removed for Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road.
A location was updated in Paterson.
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The overall status was removed for St. Joseph's Regional Medical Center.
A location was updated in Brooklyn.
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The overall status was removed for SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189.
A location was updated in Buffalo.
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The overall status was removed for Mercy Hospital of Buffalo.
A location was updated in Mineola.
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The overall status was removed for Winthrop University Hospital.
A location was updated in New Hyde Park.
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The overall status was removed for Long Island Jewish Medical Center.
A location was updated in New York.
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The overall status was removed for Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136.
A location was updated in New York.
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The overall status was removed for New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St.
A location was updated in Johnstown,.
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The overall status was removed for John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120,.
A location was updated in Philadelphia.
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The overall status was removed for Thomas Jefferson Hospital for Neuroscience.
A location was updated in Austin.
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The overall status was removed for Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street.
A location was updated in Houston.
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The overall status was removed for University of Texas Medical School in Houston.
A location was updated in Charlottesville.
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The overall status was removed for University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212.
A location was updated in Norfolk.
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The overall status was removed for Sentara Medical Group.
A location was updated in Marshfield.
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The overall status was removed for Marshfield Clinic.
A location was updated in Milwaukee.
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The overall status was removed for Medical College of Wisconsin.
A location was updated in Auchenflower.
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The overall status was removed for Wesley Medical Center.
A location was updated in Melbourne.
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The overall status was removed for Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights.
A location was updated in Innsbruck.
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The overall status was removed for Universitätsklinik für Neurologie, Anichstrasse 35, 6020 Innsbruck.
A location was updated in Wien.
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The overall status was removed for Rudolfstiftung, Neurochirurgie, Juchgasse 25, A-1030.
A location was updated in Porto Alegre.
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The overall status was removed for Hospital de Clinicas de Porto Alegre.
A location was updated in Hamilton.
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The overall status was removed for Hamilton General Hospital .237 Barton Street East.
A location was updated in London.
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The overall status was removed for London Health Sciences Center.
A location was updated in Montreal.
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The overall status was removed for CHUM Notre Dame Hospital, Department of Radiology, 1560 Sherbrooke Street.
A location was updated in Helsinki.
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The overall status was removed for Helsinki University Central Hospital, Dept. of Neurosurgery, Topeliuksenkatu 5, Helsinki, P.O. Box 266.
A location was updated in Brest cedex.
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The overall status was removed for Hôpital de la Cavale-Blanche, Service de Neurologie, Bd. Tanguy Pringent.
A location was updated in Creteil Cedex.
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The overall status was removed for CHU Henri Mondor, Service de Neuroradiologie.
A location was updated in Lille Cedex.
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The overall status was removed for Centre Hospitalier Régional et Universitaire de Lille, Clinique de Neurochirurgie, Hopital Roger Salengro, CHRU.
A location was updated in Paris.
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The overall status was removed for European Coordinating Center: Dept. of Neurology, Hôpital Lariboisière, 2 Rue Ambroise Paré, 75475 Paris cedex 10,.
A location was updated in Paris.
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The overall status was removed for Hôpital Sainte Anne, Service de Neurochirurgie, Centre Hospitalier Sainte Anne, 1, Rue Cabanis.
A location was updated in Paris cedex 10.
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The overall status was removed for Hôpital Lariboisière, Service de Neuroradiologie, 2, Rue Ambroise Paré.
A location was updated in Berlin.
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The overall status was removed for Charité Campus Benjamin Franklin (CCBF), Neurologische Klinik, Hindenburgdamm 30.
A location was updated in Dresden.
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The overall status was removed for Uniklinikum Dresden, Neuroradiologie, Fetscherstr. 74.
A location was updated in Essen.
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The overall status was removed for Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Hufelandstraße 55.
A location was updated in Frankfurt am Main.
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The overall status was removed for Uniklinikum Frankfurt, Institut für Neuroradiologie, Schleusenweg 2-16.
A location was updated in Freiburg.
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The overall status was removed for Uniklinik Freiburg, Neuroradiology-Neurocenter, Breisacher Str. 64.
A location was updated in Halle.
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The overall status was removed for Berufsgenossenschaftliche Kliniken Bergmannstrost, Klinik für Neurochirurgie, Merseburger Str. 165.
A location was updated in Hamburg.
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The overall status was removed for Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52.
A location was updated in Heidelberg.
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The overall status was removed for Universitätsklinik Heidelberg, Department of Neurosurgery, Im Neuenheimer Feld 400.
A location was updated in Munich.
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The overall status was removed for Klinikum Großhadern, LMU München, Neurologische Klinik und Poliklinik, Marchionistr. 15.
A location was updated in Bologna.
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The overall status was removed for Bellaria Hospital, Department of Neurosurgery.
A location was updated in Milano.
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The overall status was removed for Servizio di Neuroradiologia, Ospedale San Raffaele, Via Olgettina 60.
A location was updated in Seoul.
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The overall status was removed for Seoul National University Hospital.
A location was updated in Groningen.
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The overall status was removed for Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1.
A location was updated in Utrecht.
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The overall status was removed for Utrecht University Hospital, Heidelberglaan 100, 3584 CX.
A location was updated in Barcelona.
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The overall status was removed for Hospital Universitari de Bellvitge, Sección de Neuroradiologia, c/ Feixa Llarga s/n, L'Hospitalet de Llobregat.
A location was updated in Schweiz.
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The overall status was removed for Inselspital, Neurologische Klinik, 3010 Bern.
A location was updated in Bristol.
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The overall status was removed for Frenchay Hospital, Neuroradiology Department.
A location was updated in Edinburgh.
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The overall status was removed for Western General Hospital, Bramwell Dott Building, Department of Clinical Neurosciences, Crewe Road.
A location was updated in Leeds.
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The overall status was removed for Consultant Neurologist, Department of Neurology, Leeds General Infirmary, Great George Street.
A location was updated in Liverpool.
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The overall status was removed for Walton Centre for Neurology, Lower Lane Fazakerley.
A location was updated in London.
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The overall status was removed for Institute of Neurology, Box 6, The National Hospital, Queen Square.
A location was updated in Newcastle upon Tyne.
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The overall status was removed for Department of Neurosurgery, Newcastle General Hospital, Westgate Road.
A location was updated in Plymouth.
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The overall status was removed for Imaging Directorate, Derriford Hospital.
A location was updated in Preston.
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The overall status was removed for Neuroscience Department, Royal Preston Hospital, Sharoe Green Lane, Fulwood.
A location was updated in Salford.
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The overall status was removed for Department of Neurology, Hope Hospital.
A location was updated in Sheffield.
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The overall status was removed for Department of Neurology, Royal Hallamshire Hospital, Glossop Road.
6 Oct '11
The eligibility criteria were updated.
New
Inclusion Criteria: - Patient must have unruptured BAVM diagnosed by MRI/MRA and/or angiogram - Patient must be 18 years of age or older Exclusion Criteria: - Patient has evidence of recent or prior BAVM hemorrhage - Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy) - Patient has BAVM deemed untreatable by local investigator, or has concomitant vascular or brain disease that interferes with/or contradicts any invasive 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/nl) or coagulopathy (spontaneous or iatrogenic INR>1.5) - Patient is pregnant or lactating - Patient has known allergy against iodine contrast agents, multiple-foci BAVMs, or any form of arteriovenous or spinal fistulas - Patient has a diagnosed Vein of Galen type malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or 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, or hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
Old
Inclusion Criteria: - Patient must have unruptured BAVM diagnosed by MRI/MRA and/or angiogram - Patient must be 18 years of age or older Exclusion Criteria: - Patient has evidence of recent or prior BAVM hemorrhage - Patient has received prior BAVM therapy (endovascular, surgical, radiotherapy) - Patient has BAVM deemed untreatable by local investigator, or has concomitant vascular or brain disease that interferes with/or contradicts any invasive 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/nl) or coagulopathy (spontaneous or iatrogenic INR>1.5) - Patient is pregnant or lactating - Patient has known allergy against iodine contrast agents, multiple-foci BAVMs, or any form of arteriovenous or spinal fistulas - Patient has a diagnosed Vein of Galen type malformation, cavernous malformation, dural arteriovenous fistula, venous malformation, or 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, or hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)