Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
A Randomized Trial of Unruptured Brain Arteriovenous Malformations
Secondary ID [1] 0 0
U01NS051566
Secondary ID [2] 0 0
AAAB6286
Universal Trial Number (UTN)
Trial acronym
ARUBA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Arteriovenous Malformations, Cerebral 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Surgery
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Difference of 5-year event rates between two arms
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
Prevalence of the risk of death or clinical impairment at 5 years post-randomization with early intervention
Timepoint [1] 0 0
5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2015
Sample size
Target
Accrual to date
Final
226
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Wesley Medical Center - Auchenflower
Recruitment hospital [2] 0 0
Austin Health, University of Melbourne 300 Waterdale Rd,Heidelberg Heights - Melbourne
Recruitment postcode(s) [1] 0 0
4066 - Auchenflower
Recruitment postcode(s) [2] 0 0
3081 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Iowa
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
New Jersey
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Texas
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Wisconsin
Country [13] 0 0
Austria
State/province [13] 0 0
Innsbruck
Country [14] 0 0
Austria
State/province [14] 0 0
Wien
Country [15] 0 0
Brazil
State/province [15] 0 0
Porto Alegre
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Canada
State/province [17] 0 0
Quebec
Country [18] 0 0
Finland
State/province [18] 0 0
Helsinki
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France
State/province [19] 0 0
Brest cedex
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France
State/province [20] 0 0
Creteil Cedex
Country [21] 0 0
France
State/province [21] 0 0
Lille Cedex
Country [22] 0 0
France
State/province [22] 0 0
Paris cedex 10
Country [23] 0 0
France
State/province [23] 0 0
Paris
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
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Germany
State/province [25] 0 0
Dresden
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Germany
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Essen
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Germany
State/province [27] 0 0
Frankfurt am Main
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Germany
State/province [28] 0 0
Freiburg
Country [29] 0 0
Germany
State/province [29] 0 0
Halle
Country [30] 0 0
Germany
State/province [30] 0 0
Hamburg
Country [31] 0 0
Germany
State/province [31] 0 0
Heidelberg
Country [32] 0 0
Germany
State/province [32] 0 0
Munich
Country [33] 0 0
Italy
State/province [33] 0 0
Bologna
Country [34] 0 0
Italy
State/province [34] 0 0
Milano
Country [35] 0 0
Korea, Republic of
State/province [35] 0 0
Seoul
Country [36] 0 0
Netherlands
State/province [36] 0 0
Groningen
Country [37] 0 0
Netherlands
State/province [37] 0 0
Utrecht
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Switzerland
State/province [39] 0 0
Schweiz
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Bristol
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Edinburgh
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Leeds
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Liverpool
Country [44] 0 0
United Kingdom
State/province [44] 0 0
London
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Newcastle upon Tyne
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Plymouth
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Preston
Country [48] 0 0
United Kingdom
State/province [48] 0 0
Salford
Country [49] 0 0
United Kingdom
State/province [49] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Other
Name
Columbia University
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Institute of Neurological Disorders and Stroke (NINDS)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
J.P. Mohr, MS, MD
Address 0 0
Stroke Center/The Neurological Institute, Columbia University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00389181