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A Randomized Trial of Unruptured Brain AVMs (ARUBA)

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ClinicalTrials.gov Identifier: NCT00389181
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : June 4, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jay Preston Mohr, Columbia University

Tracking Information
First Submitted Date  ICMJE October 16, 2006
First Posted Date  ICMJE October 18, 2006
Last Update Posted Date June 4, 2015
Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
Difference of 5-year event rates between two arms [ Time Frame: 5 years ]
The hypothesis to be tested is that there is no difference between medical management and interventional therapy in the time to stroke or death from any cause.
Original Primary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
Composite event of death from any cause or symptomatic stroke (hemorrhage or infarction confirmed by imaging)
Change History Complete list of historical versions of study NCT00389181 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2015)
Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention [ Time Frame: 5 years ]
The hypothesis to be tested is that early intervention decreases the risk of death or clinical impairment at 5 years post-randomization. (Rankin Score >/= 2)
Original Secondary Outcome Measures  ICMJE
 (submitted: October 16, 2006)
Risk of death or clinical impairment (Rankin Score >/= 2) at 5 years post-randomization
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Trial of Unruptured Brain AVMs
Official Title  ICMJE A Randomized Trial of Unruptured Brain Arteriovenous Malformations
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Arteriovenous Malformations, Cerebral
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Medical management
    Patients with unruptured BAVMs will receive symptomatic medical management alone.
    Intervention: Other: Medical management
  • Active Comparator: Interventional therapy
    Patients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy).
    Interventions:
    • Procedure: Interventional therapy
    • Other: Medical management
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2015)
226
Original Enrollment  ICMJE
 (submitted: October 16, 2006)
800
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

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 or brain 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-Mason syndrome
  17. Patient has diagnosed BAVMs in context of moya-moya-type changes
  18. Patient has diagnosed hereditary hemorrhagic telangiectasia (Rendu-Osler-Weber)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Brazil,   Canada,   Finland,   France,   Germany,   Italy,   Korea, Republic of,   Netherlands,   Spain,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00389181
Other Study ID Numbers  ICMJE AAAB6286
U01NS051566 ( U.S. NIH Grant/Contract )
U01NS051483 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jay Preston Mohr, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: J.P. Mohr, MS, MD Stroke Center/The Neurological Institute, Columbia University
Principal Investigator: Alan J. Moskowitz, MD InCHOIR, Department of Health Policy, Mount Sinai School of Medicine
Principal Investigator: Michael Parides, PhD InCHOIR, Department of Health Policy, Mount Sinai School of Medicine, Co-PI
Principal Investigator: Christian Stapf, MD Clinical Coordinating Center, Europe
Principal Investigator: Eric Vicaut, MD Clinical Coordinating Center, Europe, Co-PI
Principal Investigator: Claudia S. Moy, PhD NINDS, Co-PI
PRS Account Columbia University
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP