Efficacy and Safety of the Liquid Embolic System (Tonbridge) for Endovascular Treatment of Cerebrovascular Malformations: a Prospective, Multi-center, Randomized, Parallel Positive Controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 14
- 主要终点
- Targeted Embolization Satisfaction Rate
研究概览
简要总结
The purpose of this study is to verify the efficacy and safety of the Liquid Embolic System (Tonbridge Medical Tech. Co., Ltd. (Suzhou)) for the treatment of cerebrovascular malformations.
详细描述
This is a prospective, multi-center, randomized, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with liquid embolic system for cerebrovascular malformations are enrolled. Eligible patients are randomized into experimental group using Liquid Embolic System (Tonbridge) or control group using Onyx Liquid Embolic System (Medtronic) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Liquid Embolic System (Tonbridge).
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
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 to 80 years, any gender;
- •Subject is suitable for endovascular treatment of cerebrovascular malformations;
- •Subject is able to understand the purpose of the study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
排除标准
- •Intracranial hemorrhage within 1 month prior to treatment;
- •The targeted embolization area needs to receive other treatments (surgical resection, SRS, other embolic materials) at the same time;
- •Combination of other cerebrovascular malformations, such as cavernous vascular malformation;
- •Severe stenosis or occlusion of cerebral feeding artery requiring surgical intervention;
- •Intracranial tumor requiring surgical intervention;
- •mRS score≥3;
- •Heart, lung, liver and renal failure or other severe diseases;
- •Known bleeding tendency, such as coagulation dysfunction (INR>1.5);
- •Known allergy to DMSO and contrast media, or contraindication to anticoagulant therapy;
- •Pregnant or breastfeeding women, or who plan to become pregnant during the study;
- •Subject is participating in other drug or medical device clinical trials at the time of signing informed consent;
- •Other conditions judged by the investigators as unsuitable for enrollment.
结局指标
主要结局
Targeted Embolization Satisfaction Rate
时间窗: intra-procedure
Targeted embolization satisfaction is defined as achieving ≥50% occlusion of the targeted embolized area after treatment with liquid embolic system, which is determined by immediate postoperative cerebrovascular DSA.
次要结局
- GOS score(1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)
- Incidence of adverse events (AEs)(1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)
- Operation satisfaction rate(intra-procedure)
- Incidence of major adverse events (MAEs)(1 month±7 days, 3 months±30 days post-procedure)
- mRS score(1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)
- Incidence of device deficiency(3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)
- Incidence of serious adverse events (SAEs)(1 month±7 days, 3 months±30 days, 6 months±30 days, 12 months±45 days post-procedure)