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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Brain arteriovenous malformations deemed suitable for liquid embolic agent intervention as assessed by the investigator
Exclusion Criteria:
* 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
* Brain arteriovenous malformation with an expected number of embolizations ≥ 4
* Brain arteriovenous malformation scheduled for surgical resection after embolization
* mRS score ≥ 3
* Subjects unsuitable for anesthesia or endovascular surgical treatment, due to major diseases of cardio, lung, liver, spleen or kidney, malignant brain tumors, severe active infection, disseminated intravascular coagulation, or a history of severe mental illness, etc
* Subjects who undergo major surgical procedures (such as tumor resection, vital organ surgery, etc.) within 30 days prior to signing the informed consent form, or those scheduled for such procedures within 60 days after signing the informed consent form
* Contraindications for liquid embolic agent treatment, including but not limited to: contraindications for DSA, severe allergy or intolerance to contrast agents, severe allergy or intolerance to antiplatelet or anticoagulant medications required for treatment, or severe allergy to tantalum metal
* Pregnant or lactating women
* Subjects participating in other drug or device studies that have not reached their endpoints or who have just withdrawn from the group for less than one month
Primary outcome measure(s)
Rate of effective embolization of target brain arteriovenous malformation — Perioperative 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
Trial sites (1)
Facility
City
Region
Status
Shanghai Changhai Hospital
Shanghai
Shanghai Municipality
Recruiting
More MicroPort NeuroTech Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.