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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00389181
Registration number
NCT00389181
Ethics application status
Date submitted
16/10/2006
Date registered
18/10/2006
Date last updated
4/06/2015
Titles & IDs
Public title
A Randomized Trial of Unruptured Brain AVMs
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Scientific title
A Randomized Trial of Unruptured Brain Arteriovenous Malformations
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Secondary ID [1]
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U01NS051566
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Secondary ID [2]
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AAAB6286
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Universal Trial Number (UTN)
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Trial acronym
ARUBA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Arteriovenous Malformations, Cerebral
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Neurological
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Other neurological disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Reproductive Health and Childbirth
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Fetal medicine and complications of pregnancy
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Surgery - Interventional therapy
Other interventions - Medical management
Experimental: Medical management - Patients with unruptured BAVMs will receive symptomatic medical management alone.
Active Comparator: Interventional therapy - Patients with unruptured BAVMs will receive symptomatic medical management with invasive therapies (any combination of surgery, endovascular embolization, or radiotherapy).
Treatment: Surgery: 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 interventions: 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.
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Intervention code [1]
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Treatment: Surgery
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Difference of 5-year event rates between two arms
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Assessment method [1]
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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.
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Timepoint [1]
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5 years
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Secondary outcome [1]
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Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention
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Assessment method [1]
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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)
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Timepoint [1]
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5 years
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/10/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2015
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Sample size
Target
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Accrual to date
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Final
226
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Wesley Medical Center - Auchenflower
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Recruitment hospital [2]
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Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights - Melbourne
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Recruitment postcode(s) [1]
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4066 - Auchenflower
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Recruitment postcode(s) [2]
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3081 - Melbourne
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Recruitment outside Australia
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Arizona
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Wisconsin
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Austria
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Innsbruck
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Austria
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Wien
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Helsinki
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France
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France
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France
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Paris
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Essen
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Germany
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Frankfurt am Main
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Newcastle upon Tyne
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Preston
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Salford
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Sheffield
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Funding & Sponsors
Primary sponsor type
Other
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Name
Columbia University
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Address
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Other collaborator category [1]
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Government body
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Name [1]
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National Institute of Neurological Disorders and Stroke (NINDS)
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00389181
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Trial related presentations / publications
Stapf C, Mohr JP, Choi JH, Hartmann A, Mast H. Invasive treatment of unruptured brain arteriovenous malformations is experimental therapy. Curr Opin Neurol. 2006 Feb;19(1):63-8. doi: 10.1097/01.wco.0000200546.14668.78.
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Public notes
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Contacts
Principal investigator
Name
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J.P. Mohr, MS, MD
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Address
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Stroke Center/The Neurological Institute, Columbia University
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00389181
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