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The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
Sponsor: MicroPort NeuroTech Co., Ltd.
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
liquid embolic agent
liquid embolic agent
Locations (1)
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China