Actively Recruiting
A Prospective, Multi-center, Open-label, Randomized Controlled Trial Comparing a Liquid Embolic Agent to the Onyx System for Treating Brain Arteriovenous Malformation
Led by MicroPort NeuroTech Co., Ltd. · Updated on 2026-01-02
116
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a prospective, multi-center, open-label, randomized controlled trial to compare a new liquid embolic agent with the Onyx Liquid Embolic System in treating brain arteriovenous malformations (AVMs). About 116 participants with brain AVMs classified by Spetzler-Martin scale from I to III will be enrolled to evaluate the safety and effectiveness of these embolic devices. This study aims to determine if the new agent is not inferior to the existing Onyx system in embolization outcomes. Participants will receive interventional embolization treatment using either the investigational liquid embolic agent developed by MicroPort NeuroTech or the Onyx Liquid Embolic System by Micro Therapeutics Inc. Both devices are used to block the abnormal blood vessels in the brain during the procedure. Follow-up visits are scheduled before surgery, after device implantation, at discharge, and at 1 month, 6 months, and 12 months after the first embolization, with additional visits as needed. Throughout the study, participants will undergo evaluations including imaging (CT/MRI/DSA) and clinical assessments to monitor embolization effectiveness and safety. Researchers will track the rate of successful embolization, clinical outcomes over one year, and any complications such as stroke, intracranial hemorrhage, or device-related adverse events. The total participation time spans up to 12 months post-procedure with regular monitoring visits.
CONDITIONS
Brief Title
The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years at the time of consent
- Diagnosed with brain arteriovenous malformation by CT, MRI, or DSA
- Brain arteriovenous malformation classified as Spetzler-Martin grade I to III
- Ability of the participant or guardian to understand the study and provide informed consent
- Brain arteriovenous malformation suitable for intervention with a liquid embolic agent as assessed by the investigator
You will not qualify if you...
- Presence of 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 prior to enrollment
- Expected number of embolizations 4 or more
- Planned surgical resection after embolization
- Modified Rankin Scale score of 3 or higher
- Unsuitability for anesthesia or endovascular surgery due to major organ diseases, malignant brain tumors, severe infections, blood clotting disorders, or severe mental illness
- Major surgery within 30 days before or planned within 60 days after consent
- Contraindications to liquid embolic agent treatment including DSA contraindications, severe allergies to contrast agents, antiplatelet or anticoagulant medications, or tantalum metal
- Pregnancy or lactation
- Participation in other drug or device studies not completed or withdrawn within the last month
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure day
Participants undergo a procedure where a liquid embolic agent or the Onyx Liquid Embolic System is used to embolize brain arteriovenous malformations.
1 procedure visit (in-person)
Duration - 1 year after procedure
Participants are monitored for safety and clinical outcomes after the embolization procedure.
Approximately monthly visits for 1 year
Trial Site Locations
Total: 1 location
1
Shanghai Changhai Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
L
Liu Shugen
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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