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
Qualifiers
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
Treatments tested in this trial
- liquid embolic agent
Treatment groups
116 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov