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A Randomized Trial of Unruptured Brain AVMs (ARUBA)

This study is currently recruiting participants.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), June 2008

Sponsors and Collaborators: Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00389181
  Purpose

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.


Condition Intervention Phase
Unruptured Brain Arteriovenous Malformation
Procedure: invasive therapy [endovascular procedures, neurosurgery, or radiotherapy, alone or in combination]
Phase III

MedlinePlus related topics:   Arteriovenous Malformations  

ChemIDplus related topics:   X-Rays  

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:   A Randomized Trial of Unruptured Brain Arteriovenous Malformations

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Composite event of death from any cause or symptomatic stroke (hemorrhage or infarction confirmed by imaging) [ Time Frame: from enrollment to study end for primary outcomes of death or symptomatic stroke including hemorrhage ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Risk of death or clinical impairment (Rankin Score >/= 2) at 5 years post-randomization [ Time Frame: from enrollment to study end for primary outcomes of death or symptomatic stroke including hemorrhage ] [ Designated as safety issue: Yes ]

Estimated Enrollment:   800
Study Start Date:   October 2006
Estimated Study Completion Date:   July 2011
Estimated Primary Completion Date:   July 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: No Intervention
symptomatic medical management alone
2: Active Comparator
symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy)
Procedure: invasive therapy [endovascular procedures, neurosurgery, or radiotherapy, alone or in combination]

All interventional procedures are standard of care for the treatment of AVMs. They are not experimental.

Endovascular procedures involve specially designed catheters/tubes position in the small arteries feeding blood to the AVM. The tubes are inserted into an artery in the groin and threaded up through the artery into the brain. Once positioned, the physician injects a special material that changes from liquid to solid very quickly. Once it solidifies, it blocks the artery that is feeding blood to the AVM.

Neurosurgery involves the opening of a portion of the skull and the brain's outer lining to get access to the AVM.

Radiosurgery involves high energy radiation (like X-rays) carefully targeted at the brain AVM to shrink it and, in the best results, eventually eliminate the artery-to-vein links and the risk of bleeding. The effect often takes one to two years to occur.


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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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, PT>30)
  • 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)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00389181

Contacts
Contact: J. P. Mohr, MS, MD     212 305 8033     jpm10@columbia.edu    
Contact: Alan J. Moskowitz, MD     212-305-9100     ajm4@columbia.edu    

 Show 54 Study Locations

Sponsors and Collaborators

Investigators
Principal Investigator:     J.P. Mohr, MS, MD     Stroke Center/The Neurological Institute, Columbia University    
Principal Investigator:     Alan J. Moskowitz, MD     InCHOIR, Columbia University    
Investigator:     Deborah Ascheim, MD     InCHOIR, Columbia University, Co-PI    
Investigator:     Annetine Gelijns, PhD     InCHOIR, Columbia University, Co-PI    
Investigator:     Michael Parides, PhD     InCHOIR, Columbia University, Co-PI    
Principal Investigator:     Christian Stapf, MD     Clinical Coordinating Center, Europe    
Investigator:     Eric Vicaut, MD     Clinical Coordinating Center, Europe, Co-PI    
Investigator:     Claudia S. Moy, PhD     NINDS, Co-PI    
  More Information

Related Info  This link exits the ClinicalTrials.gov site
 

Publications:

Publications indexed to this study:

Responsible Party:   Columbia University Medical Center ( JP Mohr MS MD Daniel Sciarra Professor of Neurology Neurological Insitute )
Study ID Numbers:   U01NS051483, U01NS051566
First Received:   October 16, 2006
Last Updated:   June 3, 2008
ClinicalTrials.gov Identifier:   NCT00389181
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
unruptured brain arteriovenous malformation  
AVM  
BAVM  
Stroke  
Intracranial Hemorrhage  

Study placed in the following topic categories:
Cardiovascular Abnormalities
Cerebral Infarction
Vascular Malformations
Stroke
Vascular Diseases
Arteriovenous Malformations
Intracranial Hemorrhages
Hemorrhage

Additional relevant MeSH terms:
Cardiovascular Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on July 03, 2008




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