NCT07314047

The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation

a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: MicroPort NeuroTech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a prospective, multi-center, open-label, non-inferiority, randomized controlled clinical trial. The control device is Onyx Liquid Embolic System marketed by Micro Therapeutics Inc. DBA ev3 Neurovascular (NMPA (J) 20173136690). According to the inclusion and exclusion criteria specified in this trial protocol, approximately 116 subjects with brain arteriovenous malformation will be enrolled for interventional embolization treatment. The subjects will undergo follow-up before the surgery, after device implantation, at discharge, 1 month (± 7 days), 6 months (± 30 days), and 12 months (± 60 days) after the first embolization. When necessary, unscheduled follow-up will be conducted to record various indicators for evaluating the safety and effectiveness of liquid embolic agents in the treatment of brain arteriovenous malformations.

Conditions

• Brain Arteriovenous Malformation
• Arteriovenous Fistula

Interventions

Type	Name	Description
DEVICE	liquid embolic agent	liquid embolic agent

Timeline

• Start date: 2024-05-28
• Primary completion: 2025-05-28
• Completion: 2026-05-28
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China