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Vascular Diseases

Neoplasms, Vascular Tissue

Neoplasms by Histologic Type

Onyx

TRUFILL

Gary Duckwiler, MD

Test whether AVMs treated with Onyx is equivalent to treatment with n-BCA. Success is defined as an AVM size reduction greater than 50%

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.

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)

Micro Therapeutics Inc.

Medtronic Neurovascular Clinical Affairs

Linda Simpson/Director of Clinical Affairs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)	NCT00857662	Brain Arteriove...	Onyx TRUFILL	-	Medtronic Neurovascular Clinical Affairs
Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)	NCT00857662	Brain Arteriove...	Onyx TRUFILL	-	Medtronic Neurovascular Clinical Affairs

Spots Global Cancer Trial Database for trufill

Every month we try and update this database with for trufill cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for trufill

Every month we try and update this database with for trufill cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for trufill cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.