The Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
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
| Condition(s) | Brain Arteriovenous Malformation, Arteriovenous Fistula |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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 embo |
| Who can participate | 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 arter |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | MicroPort NeuroTech Co., Ltd. |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2024-05-28 |
| NCT ID | NCT07314047 |
| Official listing | https://clinicaltrials.gov/study/NCT07314047 |