A Randomized Trial of Unruptured Brain Arteriovenous Malformations
18 Years
N/A
Both
Unruptured Brain Arteriovenous Malformation
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
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.
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)
Type of Study:
Interventional
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:
Yes
Principal Investigator
J.P. Mohr, MS, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Stroke Center/The Neurological Institute, Columbia University
Authority:
United States: Federal Government
Study ID:
AAAB6286
NCT ID:
NCT00389181
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
Name | Location |
|---|---|
| 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 |
