The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
NCT07314047 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 116
Last updated 2026-01-02
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.
Conditions
- Brain Arteriovenous Malformation
- Arteriovenous Fistula
Interventions
- DEVICE
-
liquid embolic agent
liquid embolic agent
Sponsors & Collaborators
-
MicroPort NeuroTech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-28
- Primary Completion
- 2025-05-28
- Completion
- 2026-05-28
Countries
- China
Study Locations
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