RecruitingNot ApplicableNCT07314047

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


Sponsor

MicroPort NeuroTech Co., Ltd.

Enrollment

116 participants

Start Date

May 28, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called liquid embolic agent for people with arteriovenous fistula and brain arteriovenous malformation. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEliquid embolic agent

liquid embolic agent


Locations(1)

Shanghai Changhai Hospital

Shanghai, Shanghai Municipality, China

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NCT07314047


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