Status:
COMPLETED
Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Collaborating Sponsors:
Micro Therapeutics Inc.
Conditions:
Brain Arteriovenous Malformations
Eligibility:
All Genders
Phase:
PHASE2
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%
Detailed Description
Recent advances in the endovascular treatment of arteriovenous malformations (AVMs) have increased the number of patients with brain AVMs for whom embolization therapy may be appropriate. The permanen...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00857662
Start Date
May 1 2001
End Date
December 1 2007
Last Update
October 27 2023
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90095