Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)
U.S. Multicenter, Randomized Controlled Study Comparing the Performance fo Onyx(EVOH) and TRUFILL® (n-BCA)in Presurgical Embolization of Brain Arteriovenous Malformations (BAVMs)
1 other identifier
interventional
117
1 country
1
Brief Summary
Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50%
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2001
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 9, 2009
CompletedOctober 27, 2023
October 1, 2023
1.9 years
March 5, 2009
October 25, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Angiographic reduction in AVM size (volume) of 50% or greater, where angiographic size reduction is defined as the change from the original AVM size prior to any embolization procedure, to the AVM size after the last embolization.
Post final embolization
Secondary Outcomes (3)
Safety will be assessed by the nature and severity of adverse events
3 months post discharge
Surgical blood loss
Surgical resection time
Study Arms (2)
Onyx
EXPERIMENTALTRUFILL
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- The patient or patient's guardian understands and will sign the informed consent for the procedure
- The patient has a confirmed diagnosis of a brain AVM in the cerebral cortex, cerebellum or dura mater as visualized by angiography or cross sectional imaging.
- The brain AVM has a Spetzler-Martin grade of I, II, III, or IV. If the brain AVM has a Spetzler-Martin grade of I or II, the anticipated benefit of embolization for surgical resection is greater than the risk of the embolization procedure (e.g., patient stability).
- The patient is a candidate for surgical resection of the AVM post embolization.
- The patient is clinically and neurologically stable, for a minimum of 24 hours prior to embolization.
- The patient agrees to have, and is capable of completing, all study-related exams and procedures.
- Patient of any age.
You may not qualify if:
- The patient is pregnant.
- The patient has a brain AVM with high flow arteriovenous fistulae that the investigator has determined to be unsuitable for embolization.
- The brain AVM has a Spetzler-Martin grade of V.
- The patient is participating in another research study involving another investigational device, procedure or drug.
- The brain AVM has been previously treated with another embolization agent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic Neurovascular Clinical Affairslead
- Micro Therapeutics Inc.collaborator
Study Sites (1)
UCLA
Los Angeles, California, 90095, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Duckwiler, MD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 9, 2009
Study Start
May 1, 2001
Primary Completion
April 1, 2003
Study Completion
December 1, 2007
Last Updated
October 27, 2023
Record last verified: 2023-10