Spots Global Cancer Trial Database for A Randomized Trial of Unruptured Brain AVMs
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Trial Identification
Brief Title: A Randomized Trial of Unruptured Brain AVMs
Official Title: A Randomized Trial of Unruptured Brain Arteriovenous Malformations
Study ID: NCT00389181
Conditions
Study Description
Brief 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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, Wien, , 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 cedex, , France
CHU Henri Mondor, Service de Neuroradiologie, Creteil Cedex, , France
Centre Hospitalier Régional et Universitaire de Lille, Clinique de Neurochirurgie, Hopital Roger Salengro, CHRU, Lille Cedex, , France
Hôpital Lariboisière, Service de Neuroradiologie, 2, Rue Ambroise Paré, Paris cedex 10, , France
Hôpital Sainte Anne, Service de Neurochirurgie, Centre Hospitalier Sainte Anne, 1, Rue Cabanis, 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, , 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, Milano, , Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1, Groningen, , Netherlands
Utrecht University Hospital, Heidelberglaan 100, 3584 CX, Utrecht, , Netherlands
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
Contact Details
Name: J.P. Mohr, MS, MD
Affiliation: Stroke Center/The Neurological Institute, Columbia University
Role: PRINCIPAL_INVESTIGATOR
Name: Alan J. Moskowitz, MD
Affiliation: InCHOIR, Department of Health Policy, Mount Sinai School of Medicine
Role: PRINCIPAL_INVESTIGATOR
Name: Michael Parides, PhD
Affiliation: InCHOIR, Department of Health Policy, Mount Sinai School of Medicine, Co-PI
Role: PRINCIPAL_INVESTIGATOR
Name: Christian Stapf, MD
Affiliation: Clinical Coordinating Center, Europe
Role: PRINCIPAL_INVESTIGATOR
Name: Eric Vicaut, MD
Affiliation: Clinical Coordinating Center, Europe, Co-PI
Role: PRINCIPAL_INVESTIGATOR
Name: Claudia S. Moy, PhD
Affiliation: NINDS, Co-PI
Role: PRINCIPAL_INVESTIGATOR
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