U.S. Multicenter, Randomized Controlled Study Comparing the Performance fo Onyx(EVOH) and TRUFILL® (n-BCA)in Presurgical Embolization of Brain Arteriovenous Malformations (BAVMs)
N/A
N/A
Both
Brain Arteriovenous Malformations
Trial Information
U.S. Multicenter, Randomized Controlled Study Comparing the Performance fo Onyx(EVOH) and TRUFILL® (n-BCA)in Presurgical Embolization of Brain Arteriovenous Malformations (BAVMs)
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 permanency of obliterated nidi and occurrence of procedural complications
are thought to be at least partially influenced by the characteristics of the material used,
with liquid agents more likely to reach and occlude the AVM nidus compared to particulate
embolic agents.
The only liquid embolic agent approved in the U.S. for the presurgical embolization of AVMs
is TRUFILL®. TRUFILL n-butyl cyanoacrylate (n-BCA) is a liquid adhesive that polymerizes
into a solid material upon contact with blood fluids or tissue, via an anionic mechanism.
TRUFILL Ethiodized Oil is mixed into the n-BCA monomer as a radiopaque polymerizing
retardant. TRUFILL Tantalum Powder may also be added for radiopacity. The TRUFILL n-BCA
Liquid Embolic System received U.S. FDA premarket approval on September 25, 2000 (P990040)
for use in the embolization of cerebral AVMs, when presurgical devascularization is desired.
Onyx™ is a non-adhesive liquid embolic agent comprised of ethylene vinyl alcohol (EVOH)
copolymer dissolved in dimethyl sulfoxide (DMSO), and of micronized tantalum powder. Onyx
precipitates into a solid on contact with blood fluids, due to rapid diffusion of the DMSO
solvent. The Onyx Liquid Embolic System received the European "CE mark" in July 1999, and
has been available outside of the U.S. since September 1999 for use in the embolization of
AVMs.
The purpose of this randomized-controlled study is to obtain prospective clinical data on
the performance of Onyx (investigational device) and TRUFILL (control device) in the
presurgical embolization of brain AVMs. Device safety will be assessed by comparing overall
and device-related morbidity and mortality. The primary efficacy endpoint is the
angiographic reduction in AVM size (volume) achieved. The objective is to demonstrate that
Onyx is no worse than TRUFILL within a specified clinical tolerance. Study results will be
used to support a premarket approval application for Onyx in the presurgical embolization of
brain AVMs.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
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.
Outcome Time Frame:
Post final embolization
Safety Issue:
No
Principal Investigator
Gary Duckwiler, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of California, Los Angeles
Authority:
United States: Food and Drug Administration
Study ID:
G000296
NCT ID:
NCT00857662
Start Date:
May 2001
Completion Date:
December 2007
Related Keywords:
- Brain Arteriovenous Malformations
- US Multicenter
- Randomized
- Onyx
- Brain Arteriovenous Malformation (BAVMs)
- Congenital Abnormalities
- Arteriovenous Malformations
- Aneurysm
- Hemangioma
Name | Location |
|---|---|
| UCLA | Los Angeles, California 90095 |
