a Prospective, Multi-center, Open-label, Non-inferiority, Randomized, Controlled Registration Trial of the Liquid Embolic Agent for the Treatment of Brain Arteriovenous Malformation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Rate of effective embolization of target brain arteriovenous malformation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of effective embolization of target brain arteriovenous malformation
时间窗: 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
次要结局
- Rate of favorable clinical outcomes during the 1 year follow-up period(1 year after procedure)
- Incidence of symptomatic stroke or death within one month after procedure(1 month after procedure)
- Incidence of symptomatic intracranial hemorrhage related to procedure within 1 month after procedure(1 month after procedure)
- Incidence of symptomatic ischemic stroke related to procedure within 1 month after procedure(1 month after procedure)
- Incidence of device-related serious adverse events during the 1 year follow-up period(1 year after procedure)