Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)

Last updated: October 25, 2023
Sponsor: Medtronic Neurovascular Clinical Affairs
Overall Status: Completed

Phase

2

Condition

Abnormal Blood Vessels (Arteriovenous Malformations)

Hemangioma

Holoprosencephaly

Treatment

TRUFILL

Onyx

Clinical Study ID

NCT00857662
G000296
  • All Genders

Study 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%

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient or patient's guardian understands and will sign the informed consent forthe 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 aSpetzler-Martin grade of I or II, the anticipated benefit of embolization for surgicalresection is greater than the risk of the embolization procedure (e.g., patientstability).
  • 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 priorto embolization.
  • The patient agrees to have, and is capable of completing, all study-related exams andprocedures.
  • Patient of any age.

Exclusion

Exclusion Criteria:

  • The patient is pregnant.
  • The patient has a brain AVM with high flow arteriovenous fistulae that theinvestigator 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 anotherinvestigational device, procedure or drug.
  • The brain AVM has been previously treated with another embolization agent

Study Design

Total Participants: 117
Treatment Group(s): 2
Primary Treatment: TRUFILL
Phase: 2
Study Start date:
May 01, 2001
Estimated Completion Date:
December 31, 2007

Study 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 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.

Connect with a study center

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

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