NCT03550638已完成不适用
The Efficacy and Safety Study on Endovascular Embolization of Intracranial Aneurysms With Coil System(Ton-bridgeMT)
Zhuhai Tonbridge Medical Tech. Co., Ltd.12 个研究点 分布在 1 个国家目标入组 256 人开始时间: 2018年5月28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
- 256
- 试验地点
- 12
- 主要终点
- success rate of occlusion
研究概览
简要总结
The study is a prospective, multi-center, randomized, open, parallel positive control, non-inferiority trial. Patients are randomized 1:1 to either Coil System(Ton-bridgeMT) or Axium Detachable Coil(Medtronic).
The purpose of this study is to assess the safety and effectiveness of the Coil System(Ton-bridgeMT) in the treatment of intracranial aneurysms.
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 18-80 years.
- •Subject has a target intracranial aneurysm (IA) diagnosed by DSA, and intended to be embolised with coil system.
- •Subject or guardian is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.
排除标准
- •Subject is diagnosed as multiple aneurysms.
- •Subject is diagnosed as intracranial bulloid, fusiform, false, dissectimng, infective aneurysm or with arteriovenous malformation.
- •mRS score≥
- •Hunt and Hess classification≥
- •Subject has emergency ruptured aneurysms and needs assisting stent.
- •The target aneurysm has received endovascular embolization or surgical treatment.
- •The aneurysm carrier artery has severe stenosis.
- •PLT<60×109/L or INR>1.
- •Subject has nonfunction of important organs or other severe diseases.
- •Major surgery in the last 30 days, or intending to receive surgical treatment in 90 days after enrollment.
- •Subject is allergic to antiplatelet drugs, anticoagulants, anesthetics, contrast agents or any related contraindication.
- •History of allergies to platinum and tungsten.
- •Expected life <12 months.
- •Pregnant or lactating women.
- •Subject has participated in any other drug or medical device clinical trials in 1 month before writting informed consent .
- •Other circumstances judged by researchers are not suitable for enrollment .
结局指标
主要结局
success rate of occlusion
时间窗: 180 day
Number of aneurysms(Raymond Ⅰ and Ⅱ)/number of overall aneurysms\*100%
次要结局
- success rate of occlusion(intraoperation)
- Recurrence rate(180 day)
研究者
研究点 (12)
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