Condition: Brain Arteriovenous Malformation · Arteriovenous Fistula · Sponsor: MicroPort NeuroTech Co., Ltd.
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.
This description comes directly from the study's public registry record.
Liu Shugen · 18353892888 · Shugen.Liu@microport.com
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| Shanghai Changhai Hospital | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07314047