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RECRUITING
NCT07314047
NA

The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation

Sponsor: MicroPort NeuroTech Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

116

Start Date

2024-05-28

Completion Date

2026-05-28

Last Updated

2026-01-02

Healthy Volunteers

No

Interventions

DEVICE

liquid embolic agent

liquid embolic agent

Locations (1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China