Clinical Trial: Study Comparing Onyx and TRUFILL in Brain Arteriovenous Malformations (AVMs)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: U.S. Multicenter, Randomized Controlled Study Comparing the Performance fo Onyx(EVOH) and TRUFILL® (n-BCA)in Presurgical Embolization of Brain Arteriovenous Malformations
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 Summary:
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 b
Sponsor: Medtronic Neurovascular Clinical Affairs
Current Primary Outcome: 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. [ Time Frame: Post final embolization ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety will be assessed by the nature and severity of adverse events [ Time Frame: 3 months post discharge ]
- Surgical blood loss
- Surgical resection time
Original Secondary Outcome:
- Safety will be assessed by the nature and severity of adverse events [ Time Frame: 3 months post discharge ]
- Blood Loss [ Time Frame: Post surgical resection ]
- Surgical resection time [ Time Frame: Post surgical resection ]
Information By: Medtronic Neurovascular Clinical Affairs
Dates:
Date Received: March 5, 2009
Date Started: May 2001
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017
