Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Randomized, Open, Parallel Positive Controlled, Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 204
- 试验地点
- 28
- 主要终点
- Successful occlusion rate of aneurysms at 6 months
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of Self-expanding Intracranial Stent (Tonbridge), by comparing the data obtained from Self-expanding Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) and LVIS/LVIS Jr. (MicroVention Europe SARL) for endovascular treatment of intracranial aneurysms.
详细描述
This is a prospective, multi-center, randomized, open, 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 stent-assisted coiling for intracranial aneurysms are enrolled. Eligible patients are randomized into experimental group using Self-expanding Intracranial Stent (Tonbridge) or control group using LVIS and LVIS Jr. (MicroVention) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Self-expanding Intracranial Stent (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;
- •Diagnosed as intracranial aneurysm and the subject is assessed as suitable for stent-assisted coiling;
- •Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.
排除标准
- •Aneurysm rupture within 30 days before enrollment;
- •Diagnosed as blood blister-like aneurysm, pseudoaneurysm, infected aneurysm, or aneurysm related to arteriovenous malformations;
- •Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
- •Modified Rankin Scale (mRS) score ≥3;
- •Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);
- •Major surgery within 30 days before enrollment；
- •Known coagulation dysfunction or contraindication to anticoagulant and antiplatelet therapy;
- •Known allergy to nickel-titanium alloy metal materials;
- •Life expectancy <12 months;
- •Pregnant or breastfeeding women;
- •Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent;
- •Other conditions judged by the investigators as unsuitable for enrollment.
结局指标
主要结局
Successful occlusion rate of aneurysms at 6 months
时间窗: 6 months±30 days post-procedure
Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by cerebrovascular DSA at 6 months post-procedure.
次要结局
- Incidence of serious adverse events(180±30 days, 360±30 days post-procedure)
- Retreatment rate(180±30 days, 360±30 days post-procedure)
- Incidence of parent artery occlusion in target area(180±30 days, 360±30 days post-procedure)
- Incidence of stroke(30±7 days, 360±30 days post-procedure)
- Device success rate(intra-procedure)
- All-cause mortality(30±7 days, 360±30 days post-procedure)
- Immediate successful occlusion rate of aneurysms(intra-procedure)
- Incidence of adverse events(180±30 days, 360±30 days post-procedure)
- Recurrence rate of aneurysms at 6 months(6 months±30 days post-procedure)
- Operation satisfaction rate(intra-procedure)
- Incidence of parent artery stenosis (>50%) in target area(180±30 days, 360±30 days post-procedure)
- Incidence of device deficiency(intra-procedure, 180±30 days post-procedure)