A Randomized Trial of Unruptured Brain AVMs

Last updated: June 2, 2015
Sponsor: Columbia University
Overall Status: Completed

Phase

3

Condition

Hemangioma

Birth Defects

Abnormal Blood Vessels (Arteriovenous Malformations)

Treatment

N/A

Clinical Study ID

NCT00389181
AAAB6286
U01NS051566
U01NS051483
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 HealthInsurance Portability and Accountability Act (HIPAA/U.S. only) Forms

Exclusion

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 orbrain 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-Masonsyndrome

  17. Patient has diagnosed BAVMs in context of moya-moya-type changes

  18. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)

Study Design

Total Participants: 226
Study Start date:
October 01, 2006
Estimated Completion Date:
May 31, 2015

Study 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.

Connect with a study center

  • Wesley Medical Center

    Auchenflower, Queensland 4066
    Australia

    Site Not Available

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

    Melbourne, Victoria 3081
    Australia

    Site Not Available

  • Universitätsklinik für Neurologie, Anichstrasse 35, 6020 Innsbruck

    Innsbruck,
    Austria

    Site Not Available

  • Rudolfstiftung, Neurochirurgie, Juchgasse 25, A-1030

    Wien,
    Austria

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre,
    Brazil

    Site Not Available

  • Hamilton General Hospital .237 Barton Street East

    Hamilton, Ontario L8L 2X2
    Canada

    Site Not Available

  • London Health Sciences Center

    London, Ontario N6A 5W9
    Canada

    Site Not Available

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

    Montreal, Quebec H2L 4M1
    Canada

    Site Not Available

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

    Helsinki, FI-00029 HUS
    Finland

    Site Not Available

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

    Brest cedex, 29609
    France

    Site Not Available

  • CHU Henri Mondor, Service de Neuroradiologie

    Creteil Cedex, 94010
    France

    Site Not Available

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

    Lille Cedex, 59037
    France

    Site Not Available

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

    Paris,
    France

    Site Not Available

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

    Paris, 75014
    France

    Site Not Available

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

    Paris cedex 10, 75475
    France

    Site Not Available

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

    Berlin, 12200
    Germany

    Site Not Available

  • Uniklinikum Dresden, Neuroradiologie, Fetscherstr. 74

    Dresden, 01307
    Germany

    Site Not Available

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

    Essen, 45147
    Germany

    Site Not Available

  • Uniklinikum Frankfurt, Institut für Neuroradiologie, Schleusenweg 2-16

    Frankfurt am Main, 60528
    Germany

    Site Not Available

  • Uniklinik Freiburg, Neuroradiology-Neurocenter, Breisacher Str. 64

    Freiburg, 79106
    Germany

    Site Not Available

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

    Halle, 06112
    Germany

    Site Not Available

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

    Hamburg, 20246
    Germany

    Site Not Available

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

    Heidelberg, 69120
    Germany

    Site Not Available

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

    Munich, 81377
    Germany

    Site Not Available

  • Bellaria Hospital, Department of Neurosurgery

    Bologna, 40139
    Italy

    Site Not Available

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

    Milano, 20131
    Italy

    Site Not Available

  • Seoul National University Hospital

    Seoul, 1 10-744
    Korea, Republic of

    Site Not Available

  • Department of Neurosurgery, Universitair Medisch Centrum Groningen Hanzeplein 1

    Groningen, 9700
    Netherlands

    Site Not Available

  • Utrecht University Hospital, Heidelberglaan 100, 3584 CX

    Utrecht,
    Netherlands

    Site Not Available

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

    Barcelona, 08907
    Spain

    Site Not Available

  • Inselspital, Neurologische Klinik, 3010 Bern

    Schweiz,
    Switzerland

    Site Not Available

  • Frenchay Hospital, Neuroradiology Department

    Bristol, BS 16 1LE
    United Kingdom

    Site Not Available

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

    Edinburgh, EH4 2XU
    United Kingdom

    Site Not Available

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

    Leeds, LS1 3EX
    United Kingdom

    Site Not Available

  • Walton Centre for Neurology, Lower Lane Fazakerley

    Liverpool, L9 7LJ
    United Kingdom

    Site Not Available

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

    London, WC12N 3BG
    United Kingdom

    Site Not Available

  • Department of Neurosurgery, Newcastle General Hospital, Westgate Road

    Newcastle upon Tyne, NE4 6BE
    United Kingdom

    Site Not Available

  • Imaging Directorate, Derriford Hospital

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

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

    Preston, PR2 9HP
    United Kingdom

    Site Not Available

  • Department of Neurology, Hope Hospital

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Department of Neurology, Royal Hallamshire Hospital, Glossop Road

    Sheffield, 810 2JF
    United Kingdom

    Site Not Available

  • University of South Alabama, Stroke Center, 2451 Fillingim Street, Suite 10I

    Mobile, Alabama 36617-2238
    United States

    Site Not Available

  • Barrow Neurological Institute, 350 West Thomas Road

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd

    Los Angeles, California 90027
    United States

    Site Not Available

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

    Los Angeles, California 90095-1769
    United States

    Site Not Available

  • Kaiser Permanente (SF)

    Redwood City, California 94063
    United States

    Site Not Available

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

    San Francisco, California 94110
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33146
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

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

    Maywood, Illinois 60153-3304
    United States

    Site Not Available

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

    Iowa City, Iowa 52242-1009
    United States

    Site Not Available

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

    Southfield, Michigan 48075
    United States

    Site Not Available

  • St. Louis University School of Medicine,1438 S. Grand Blvd.

    St. Louis, Missouri 63104
    United States

    Site Not Available

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey 07503
    United States

    Site Not Available

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

    Brooklyn, New York 11203-2098
    United States

    Site Not Available

  • Mercy Hospital of Buffalo

    Buffalo, New York 14220
    United States

    Site Not Available

  • Winthrop University Hospital

    Mineola, New York 11501
    United States

    Site Not Available

  • Long Island Jewish Medical Center

    New Hyde Park, New York 11040
    United States

    Site Not Available

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

    New York, New York 10029
    United States

    Site Not Available

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

    New York, New York 10032
    United States

    Site Not Available

  • Wake Forest University School of Medicine, Department of Neurology, Medical Center Boulevard

    Winston Salem, North Carolina 27157-1029
    United States

    Site Not Available

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

    Johnstown,, Pennsylvania 15904
    United States

    Site Not Available

  • Thomas Jefferson Hospital for Neuroscience

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • University of Pittsburgh Medical Center, Health System Stroke Institute, 200 Lothrop Street- C-400 PUH

    Pittsburgh, Pennsylvania 15213-2582
    United States

    Site Not Available

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

    Austin, Texas 78701
    United States

    Site Not Available

  • University of Texas Medical School in Houston

    Houston, Texas 77030
    United States

    Site Not Available

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

    Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Sentara Medical Group

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Seattle Neuroscience Institute/Swedish Medical, 550 17th Avenue, Suite 500

    Seattle, Washington 98122
    United States

    Site Not Available

  • Marshfield Clinic

    Marshfield, Wisconsin 54449
    United States

    Site Not Available

  • Medical College of Wisconsin

    Milwaukee, Wisconsin 53226-4874
    United States

    Site Not Available

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