NCT04918420已完成不适用
Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Single-arm Trial
Ton-Bridge Medical Tech. Co., Ltd13 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2021年7月7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
- 142
- 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 effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive endovascular treatment of intracranial aneurysms.
详细描述
This is a prospective, multi-center, single-arm clinical trial carried out in 7 research centers over China. In this study, enrolled patients are treated with the Flow Diverter (Tonbridge) for intracranial aneurysms. The objective of this study is to evaluate the effectiveness and safety of the Flow Diverter (Tonbridge) for treatment of intracranial aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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;
- •A single unruptured intracranial aneurysm locates in the intracranial segment of internal carotid artery (ICA) or vertebral artery (VA), which diagnosed by DSA;
- •The maximal diameter of the target aneurysm < 10 mm diagnosed by DSA;
- •The target aneurysm with a neck ≥ 4 mm or a dome to neck ratio < 2 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 with cerebrovascular malformations;
- •Intracranial hemorrhage within 30 days pre-procedure;
- •Modified Rankin Scale (mRS) score ≥ 3 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 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);
- •Subject who 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, stent in the target lesion of parent artery, 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±30 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
- Immediate procedural success rate(intra-procedure)
- Incidence of new-onset stroke in the territory supplied by the treated artery or neurologic death at 12 months(360±30 days post-procedure)
- Incidence of any stroke(30±7 days, 360±30 days post-procedure)
- Incidence of parent artery occlusion in target area at 12 months(360±30 days post-procedure)
- Incidence of serious adverse events(pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure)
- Operation satisfaction rate(intra-procedure)
- Complete occlusion rate of aneurysms at 6 months(180±30 days post-procedure)
- Successful occlusion rate of aneurysms at 12 months(360±30 days post-procedure)
- Incidence of technical complications(intra-procedure)
- Incidence of parent artery stenosis ( > 50%）in target area at 12 months(360±30 days post-procedure)
- Incidence of adverse events(pre-procedure, intra-procedure, within 24 hours, 30±7 days, 90±14 days, 180±30 days, 360±30 days post-procedure)
- Incidence of device deficiency(intra-procedure, 360±30 days post-procedure)
- Mortality rate(30±7 days, 360±30 days post-procedure)
研究者
研究点 (13)
Loading locations...
相似试验
已完成
不适用
Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial AneurysmsIntracranial AneurysmNCT04799964Zhuhai Tonbridge Medical Tech. Co., Ltd.187
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
终止
不适用
Study on Fistuloplasty Using Flow Measurement GuidanceEnd Stage Renal Failure on DialysisRenal FailureNCT01643733Richard Lindsay26
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