A Prospective, Multi-center, Open-label, Randomized Trial Comparing Liquid Embolic Agents for Treating Brain Arteriovenous Malformation

What this Trial Is About

Researchers are conducting a prospective, multi-center, open-label, randomized controlled trial to compare a new liquid embolic agent with the Onyx Liquid Embolic System in treating brain arteriovenous malformations AVMs. About 116 participants with brain AVMs classified by Spetzler-Martin scale from I to III will be enrolled to evaluate the safety and effectiveness of these embolic devices. This study aims to determine if the new agent is not inferior to the existing Onyx system in embolization outcomes. Participants will receive interventional embolization treatment using either the investigational liquid embolic agent developed by MicroPort NeuroTech or the Onyx Liquid Embolic System by Micro Therapeutics Inc. Both devices are used to block the abnormal blood vessels in the brain during the procedure. Follow-up visits are scheduled before surgery, after device implantation, at discharge, and at 1 month, 6 months, and 12 months after the first embolization, with additional visits as needed. Throughout the study, participants will undergo evaluations including imaging CTMRIDSA and clinical assessments to monitor embolization effectiveness and safety. Researchers will track the rate of successful embolization, clinical outcomes over one year, and any complications such as stroke, intracranial hemorrhage, or device-related adverse events. The total participation time spans up to 12 months post-procedure with regular monitoring visits.

The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation