NCT04799964已完成不适用
Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: a Prospective, Multi-center, Randomized, Open, Positive-controlled, Non-inferiority Trial
Zhuhai Tonbridge Medical Tech. Co., Ltd.13 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2021年8月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 13
- 主要终点
- Complete occlusion rate of aneurysms at 12 months
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.
详细描述
This is a prospective, multi-center, randomized, open, positive-controlled, non-inferiority trial. This clinical trial is conducted at more than 5 centers in China. Eligible patients are randomized into experimental group using Flow Diverter (Tonbridge) or control group using Tubridge (MicroPort) in a 1:1 ratio. The primary objective of this study is to verify the complete occlusion rate of aneurysms at 12 months of Flow Diverter (Tonbridge) is non-inferior to Tubridge, for treatment of intracranial aneurysms, and evaluate the effectiveness and safety of the Flow Diverter (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;
- •Unruptured intracranial aneurysms locate in the internal carotid artery (ICA) or vertebral artery (VA) with a neck ≥ 4 mm and a maximal diameter ≥ 10 mm, which diagnosed by DSA;
- •The target aneurysm with a parent vessel diameter of 2.0-6.5 mm;
- •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
- •Diagnosed as multiple aneurysms which cannot be covered by a single stent or with cerebrovascular malformations;
- •Subarachnoid hemorrhage of the target aneurysm within 30 days pre-procedure;
- •Modified Rankin Scale (mRS) score > 2 in pre-procedure;
- •Platelet (PLT) < 60×10^9/L or known platelet dysfunction or International Normalized Ratio (INR) > 1.5;
- •Heart, lung, liver and renal failure or other severe diseases (such as brain tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis);
- •The lesion which is not appropriate for flow diverter delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, etc.);
- •Major surgery within 30 days before enrollment, or intending to receive surgery within 180 days after enrollment;
- •Allergic history of anesthetics and contrast agents, or contraindication for dual antiplatelet or/and anticoagulant therapy;
- •Allergic History of metals such as nickel-titanium alloy;
- •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
Complete occlusion rate of aneurysms at 12 months
时间窗: 360±45 days post-procedure
Complete occlusion is defined as no contrast agent in the aneurysm (Raymond-Roy class I) which is diagnosed by cerebrovascular DSA at 12 months post-procedure.
次要结局
- Subtotal occlusion rate(360±45 days post-procedure)
- Incidence of technical complications(intra-procedure)
- Incidence of stroke(within 360±45 days)
- Operation satisfaction rate(intra-procedure)
- Immediate procedural success rate(intra-procedure)
- Complete occlusion rate of aneurysms at 6 months(180±30 days post-procedure)
- Incidence of parent artery stenosis ( > 50%) in target area at 360 days and incidence of parent artery occlusion in target area at 360 days(360±45 days post-procedure)
- Incidence of device deficiency(within 360±45 days)
- Incidence of adverse events and incidence of serious adverse events(within 360±45 days)
- Mortality rate(within 360±45 days)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
不适用
A Single-arm Trial of the Flow Diverter (Tonbridge) For Endovascular Treatment of Intracranial AneurysmsIntracranial AneurysmNCT04918420Ton-Bridge Medical Tech. Co., Ltd142
进行中（未招募）
不适用
Tubridge Flow Diverter Study For Intracranial AneurysmsIntracranial AneurysmNCT05646108MicroPort NeuroTech Co., Ltd.5,000
已完成
不适用
The Safety and Efficiency of Stent-based Diverting Technique Versus Ileostomy in Rectal Cancer PatientsRectal NeoplasmsNCT06204497Sir Run Run Shaw Hospital570
Unknown
不适用
PROSPECTIVE, MULTI-CENTER, OPEN-LABEL, SINGLE-ARM REGISTRATION TRIAL OF THE TUBRIDGE FOR THE TREATMENT OF WIDE-NECKED SMALL AND MEDIUM-SIZED INTRACRANIAL ANEURYSMSBrain DiseasesCardiovascular DiseasesAneurysmIntracranial AneurysmNCT05829746MicroPort NeuroTech Co., Ltd.65
已完成
不适用
Safety and Efficacy of the Vascular Closure Device (Tonbridge) in Hemostasis Treatment of Femoral Artery PunctureVascular ClosureEndovascular ProcedureHemostasisFemoral ArteryPunctureNCT05822804Ton-Bridge Medical Tech. Co., Ltd228