The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMicroPort NeuroTech Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 and ≤ 80 years at the time of signing the informed consent
Subjects with brain arteriovenous malformation diagnosed by CT/MRI/DSA
The target brain arteriovenous malformation is classified by Spetzler-Martin in the range of Ⅰ ~ Ⅳ
Subjects themselves and/or their guardian are able to understand the purpose of the study, consent to participate, and sign the informed consent form
Disqualifiers
Multiple brain arteriovenous malformations
Brain arteriovenous malformation complicated with blood flow-related aneurysm that may require staged and delayed treatment using other methods within the one-year follow-up period
Brain arteriovenous malformation with a history of stereotactic radiosurgery within 3 years
Brain arteriovenous malformation with bleeding within 1 week
Trial design
Design model
Parallel
Treatments tested in this trial
liquid embolic agent
Deviceliquid embolic agent
Treatment groups
116 Participants
are divided into 2 treatment groupsGroup A: Liquid embolic agentExperimental treatment 1 intervention
Group B: the Onyx Liquid Embolic SystemActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate 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
PerioperativeSecondary outcomes
1
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 procedure2
Incidence of symptomatic stroke or death within one month after procedure
Time frame
1 month after procedure3
Incidence of symptomatic intracranial hemorrhage related to procedure within 1 month after procedure
Time frame
1 month after procedure4
Incidence of symptomatic ischemic stroke related to procedure within 1 month after procedure
Time frame
1 month after procedureSponsors and contacts
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Source ClinicalTrials.gov