Actively Recruiting
The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
Led by MicroPort NeuroTech Co., Ltd. · Updated on 2026-01-02
116
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years at the time of signing informed consent
- Diagnosed brain arteriovenous malformation confirmed by CT, MRI, or DSA
- Target brain arteriovenous malformation classified as Spetzler-Martin grade I to III
- Ability to understand the study purpose and provide informed consent
- Brain arteriovenous malformation suitable for liquid embolic agent treatment as assessed by the investigator
You will not qualify if you...
- Multiple brain arteriovenous malformations
- Brain arteriovenous malformation with blood flow-related aneurysm requiring staged or delayed treatment within one year
- History of stereotactic radiosurgery for brain arteriovenous malformation within 3 years
- Brain arteriovenous malformation with bleeding within 1 week
- Expected number of embolization treatments 4 or more
- Scheduled for surgical resection after embolization
- Modified Rankin Scale score of 3 or higher
- Unsuitable for anesthesia or endovascular surgery due to major organ diseases, malignant brain tumors, severe infections, coagulation disorders, or severe mental illness
- Major surgery within 30 days before or planned within 60 days after informed consent
- Contraindications to liquid embolic agent treatment, including contraindications for DSA or severe allergies to contrast agents, antiplatelet/anticoagulant medications, or tantalum metal
- Pregnant or lactating women
- Participation in other drug or device studies without completion or recent withdrawal within one month
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
L
Liu Shugen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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