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A Randomized Trial of Unruptured Brain Arteriovenous Malformations

Phase 3
18 Years
Open (Enrolling)
Unruptured Brain Arteriovenous Malformation

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Trial Information

A Randomized Trial of Unruptured Brain Arteriovenous Malformations

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

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

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

- 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)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Composite event of death from any cause or symptomatic stroke (hemorrhage or infarction confirmed by imaging)

Outcome Time Frame:

from enrollment to study end for primary outcomes of death or symptomatic stroke including hemorrhage

Safety Issue:


Principal Investigator

J.P. Mohr, MS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stroke Center/The Neurological Institute, Columbia University


United States: Federal Government

Study ID:




Start Date:

October 2006

Completion Date:

July 2017

Related Keywords:

  • Unruptured Brain Arteriovenous Malformation
  • unruptured brain arteriovenous malformation
  • AVM
  • BAVM
  • Stroke
  • Intracranial Hemorrhage
  • Congenital Abnormalities
  • Arteriovenous Malformations
  • Aneurysm
  • Hemangioma



Marshfield Clinic Marshfield, Wisconsin  54449
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Rush University Medical Center Chicago, Illinois  60612-3824
Winthrop University Hospital Mineola, New York  11501
Long Island Jewish Medical Center New Hyde Park, New York  11040
University of Miami Miami, Florida  33136
Barrow Neurological Institute, 350 West Thomas Road Phoenix, Arizona  85013
University of California at Los Angeles, UCLA School of Medicine, 710 Westwood Plaza Los Angeles, California  90095-1769
Kaiser Permanente Los Angeles Medical Center,4867 Sunset Blvd Los Angeles, California  90027
Kaiser Permanente (SF) Redwood City, California  94063
University of California at San Francisco, 1001 Potrero Avenue- Rm 3C-38 San Francisco, California  94110
Loyola University Stritch School of Medicine, Department of Neurology, 2160 S 1st Ave, Bldg 105/2700 Maywood, Illinois  60153-3304
University of Iowa Hospitals, Department of Neurology, 200 Hawkins Drive , Iowa City, Iowa  52242-1009
Michigan Head and Spine Institute, Providence Hospital and Medical Center, 16001 West Nine Mile Road Southfield, Michigan  48075
St. Joseph's Regional Medical Center Paterson, New Jersey  07503
SUNY Downstate Medical Center, 451 Clarkson Avenue, Box 1189 Brooklyn, New York  11203-2098
Mercy Hospital of Buffalo Buffalo, New York  14220
Mount Sinai Hospital, One Gustave L. Levy Place, Department of Neurosurgery- Box 1136 New York, New York  10029
New York Presbyterian Hospital, Columbia Campus, Neurological Institute, 710 W. 168th St New York, New York  10032
John P. Murtha Neuroscience & Pain Institute,1450 Scapl Ave, Suite 120, Johnstown,, Pennsylvania  15904
Thomas Jefferson Hospital for Neuroscience Philadelphia, Pennsylvania  19107
Brackenridge Hospital, Brain and Spine Center, 601 East 15th Street Austin, Texas  78701
University of Texas Medical School in Houston Houston, Texas  77030
University of Virginia School of Medicine, Department of Neurosurgery, P.O. Box 800212 Charlottesville, Virginia  22908
Sentara Medical Group Norfolk, Virginia  23502