A Randomized Trial of Unruptured Brain AVMs

PHASE3CompletedINTERVENTIONAL
Enrollment

226

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

June 30, 2013

Study Completion Date

May 31, 2015

Conditions
Arteriovenous Malformations, Cerebral
Interventions
PROCEDURE

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.

OTHER

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.

Trial Locations (66)

3081

Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights, Melbourne

4066

Wesley Medical Center, Auchenflower

9700

Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1, Groningen

10029

Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136, New York

10032

New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St, New York

11040

Long Island Jewish Medical Center, New Hyde Park

11501

Winthrop University Hospital, Mineola

12200

Charité Campus Benjamin Franklin (CCBF), Neurologische Klinik, Hindenburgdamm 30, Berlin

14220

Mercy Hospital of Buffalo, Buffalo

15904

John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120,, Johnstown

19107

Thomas Jefferson Hospital for Neuroscience, Philadelphia

20131

Servizio di Neuroradiologia, Ospedale San Raffaele, Via Olgettina 60, Milan

20246

Department of Neuroradiology, University Medical Center Hamburg-Eppendorf, Martinistrasse 52, Hamburg

22908

University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212, Charlottesville

23502

Sentara Medical Group, Norfolk

29609

Hôpital de la Cavale-Blanche, Service de Neurologie, Bd. Tanguy Pringent, Brest

33146

University of Miami, Miami

40139

Bellaria Hospital, Department of Neurosurgery, Bologna

45147

Universitätsklinikum Essen, Institut für Diagnostische und Interventionelle Radiologie und Neuroradiologie, Hufelandstraße 55, Essen

48075

Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road, Southfield

54449

Marshfield Clinic, Marshfield

59037

Centre Hospitalier Régional et Universitaire de Lille, Clinique de Neurochirurgie, Hopital Roger Salengro, CHRU, Lille

60528

Uniklinikum Frankfurt, Institut für Neuroradiologie, Schleusenweg 2-16, Frankfurt am Main

60612

Rush University Medical Center, Chicago

69120

Universitätsklinik Heidelberg, Department of Neurosurgery, Im Neuenheimer Feld 400, Heidelberg

75014

Hôpital Sainte Anne, Service de Neurochirurgie, Centre Hospitalier Sainte Anne, 1, Rue Cabanis, Paris

75475

Hôpital Lariboisière, Service de Neuroradiologie, 2, Rue Ambroise Paré, Paris

77030

University of Texas Medical School in Houston, Houston

78701

Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street, Austin

79106

Uniklinik Freiburg, Neuroradiology-Neurocenter, Breisacher Str. 64, Freiburg im Breisgau

81377

Klinikum Großhadern, LMU München, Neurologische Klinik und Poliklinik, Marchionistr. 15, Munich

85013

Barrow Neurological Institute, 350 West Thomas Road, Phoenix

90027

Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd, Los Angeles

94010

CHU Henri Mondor, Service de Neuroradiologie, Créteil

94063

Kaiser Permanente (SF), Redwood City

94110

University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38, San Francisco

90095-1769

University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza, Los Angeles

60153-3304

Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700, Maywood

52242-1009

University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive ,, Iowa City

07503

St. Joseph's Regional Medical Center, Paterson

11203-2098

SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189, Brooklyn

53226-4874

Medical College of Wisconsin, Milwaukee

Unknown

Universitätsklinik für Neurologie, Anichstrasse 35, 6020 Innsbruck, Innsbruck

Rudolfstiftung, Neurochirurgie, Juchgasse 25, A-1030, Vienna

Hospital de Clinicas de Porto Alegre, Porto Alegre

European Coordinating Center: Dept. of Neurology, Hôpital Lariboisière, 2 Rue Ambroise Paré, 75475 Paris cedex 10,, Paris

Utrecht University Hospital, Heidelberglaan 100, 3584 CX, Utrecht

Inselspital, Neurologische Klinik, 3010 Bern, Schweiz

L8L 2X2

Hamilton General Hospital .237 Barton Street East, Hamilton

N6A 5W9

London Health Sciences Center, London

H2L 4M1

CHUM Notre Dame Hospital, Department of Radiology, 1560 Sherbrooke Street, Montreal

FI-00029 HUS

Helsinki University Central Hospital, Dept. of Neurosurgery, Topeliuksenkatu 5, Helsinki, P.O. Box 266, Helsinki

01307

Uniklinikum Dresden, Neuroradiologie, Fetscherstr. 74, Dresden

06112

Berufsgenossenschaftliche Kliniken Bergmannstrost, Klinik für Neurochirurgie, Merseburger Str. 165, Halle

1 10-744

Seoul National University Hospital, Seoul

08907

Hospital Universitari de Bellvitge, Sección de Neuroradiologia, c/ Feixa Llarga s/n, L'Hospitalet de Llobregat, Barcelona

BS 16 1LE

Frenchay Hospital, Neuroradiology Department, Bristol

EH4 2XU

Western General Hospital, Bramwell Dott Building, Department of Clinical Neurosciences, Crewe Road, Edinburgh

LS1 3EX

Consultant Neurologist, Department of Neurology, Leeds General Infirmary, Great George Street, Leeds

L9 7LJ

Walton Centre for Neurology, Lower Lane Fazakerley, Liverpool

WC12N 3BG

Institute of Neurology, Box 6, The National Hospital, Queen Square, London

NE4 6BE

Department of Neurosurgery, Newcastle General Hospital, Westgate Road, Newcastle upon Tyne

PL6 8DH

Imaging Directorate, Derriford Hospital, Plymouth

PR2 9HP

Neuroscience Department, Royal Preston Hospital, Sharoe Green Lane, Fulwood, Preston

M6 8HD

Department of Neurology, Hope Hospital, Salford

810 2JF

Department of Neurology, Royal Hallamshire Hospital, Glossop Road, Sheffield

All Listed Sponsors
collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

NIH

lead

Columbia University

OTHER

NCT00389181 - A Randomized Trial of Unruptured Brain AVMs | Biotech Hunter | Biotech Hunter