A Prospective, Multi-center, Randomized Parallel Controlled Study on the Safety and Effectiveness of the Non-adhesive Liquid Embolic System in the Embolization of Cerebral Arteriovenous Malformations
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
- 13
- 主要终点
- Effective embolization rate of malformed masses
研究概览
简要总结
This clinical trial is to verify the safety and effectiveness of the Non-adhesive Liquid Embolic System(NALES) produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. in the process of clinical use to support the application of the National Medical Products Administration ( NMPA) product registration approval.
详细描述
A prospective, multicenter, randomized controlled trial was used in this study. Onyx Liquid Embolic System and Marathon Flow Directed Micro Catheter, which were registered and marketed in China and had good effect in the industry, were selected as the control devices. Subjects requiring cerebral arteriovenous malformation embolization were selected to participate in the trial based on pathological conditions and inclusion/exclusion criteria, and the use of test products or control products was determined based on central randomized results. Imaging data involving the main evaluation criteria were evaluated uniformly by the blind evaluators of the leading unit, so as to reduce the bias caused by subjective factors of different evaluators.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years old, no gender limit.
- •The patient was diagnosed as cerebral arteriovenous malformation .
- •The patient had no history of bAVM treatment, including intervention, surgery or radiotherapy .
- •Spetzler Martin, grade I-IV .
- •The patient voluntarily signed the informed consent.
排除标准
- •History of heparin allergy.
- •The patient is allergic to contrast media.
- •Severe hepatic and renal insufficiency (serum creatinine ≥1.5 times the upper limit of normal value, alanine aminotransferase ≥3 times the upper limit of normal value, aspartate aminotransferase ≥3 times the upper limit of normal value).
- •Patient has irreversible coagulopathy (INR > 1.5).
- •Intracranial hemorrhage 1 week before treatment.
- •MRS ≥4 due to neurological dysfunction.
- •Patients with planned malformation resection after embolization.
- •Blood flow related aneurysms of supplying artery that need to be treated by other methods.
- •Complicated with severe cerebral artery stenosis.
- •Brain tumors that require recent surgery.
- •Complicated with proliferative cerebrovascular disease.
- •Pregnant or lactating women.
- •Participants who have participated in other clinical trials within the last 3 months and failed to reach the end point.
- •The number of embolism is expected to be greater than or equal to 4 times during the study period (within 1 year).
- •Subjects deemed unsuitable for this study by the investigator.
结局指标
主要结局
Effective embolization rate of malformed masses
时间窗: Immediately after surgery
Number of effective embolization subjects / Total number of subjects x 100%.Definition of effective embolization : Postoperative DSA angiographic malformation volume decreased ≥50%. Volume of malformed groups = length × width × height /2.
次要结局
- Catheter performance evaluation(Immediately after surgery)
- Technical success rate(Immediately after surgery)
- MRS score(1,6,12months after surgery)