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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
116
liquid embolic agent
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGRate of effective embolization of target brain arteriovenous malformation
Effective embolization refers to a reduction of ≥ 50% after the last embolization of the target brain arteriovenous malformation compared with that before the first embolization
Time frame: Perioperative
Rate of favorable clinical outcomes during the 1 year follow-up period
Favorable clinical outcome refers to a mRS score of ≥ 0 and ≤ 2
Time frame: 1 year after procedure
Incidence of symptomatic stroke or death within one month after procedure
Time frame: 1 month after procedure
Incidence of symptomatic intracranial hemorrhage related to procedure within 1 month after procedure
Time frame: 1 month after procedure
Incidence of symptomatic ischemic stroke related to procedure within 1 month after procedure
Time frame: 1 month after procedure
Incidence of device-related serious adverse events during the 1 year follow-up period
Time frame: 1 year after procedure
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