NCT05119647已完成不适用
The Efficacy and Safety Study of Thrombus Aspiration Catheter(Ton-bridgeMT) on Endovascular Treatment of Acute Ischemic Stroke
Zhuhai Tonbridge Medical Tech. Co., Ltd.15 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2022年2月11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
- 124
- 试验地点
- 15
- 主要终点
- Successful recanalization rate within three-times aspiration
研究概览
简要总结
This is a prospective multicenter, single-arm objective performance criteria trial to assess the efficacy and safety of the the thrombus aspiration catheter.
详细描述
The study is conducted in 15 centers all around China, aiming at recruiting 155 patients with acute stroke caused by artery occlusion.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Baseline NIHSS score ≥6;
- •Subject has acute occlusion located in Vertebral artery(VA) / Internal Carotid Artery (ICA) / M1or M2 segment of Middle Cerebral Artery (MCA) / Basilar artery (BA) diagnosed by DSA;
- •Femoral artery puncture is expected to be completed within 24 hours of onset；
- •mRS score≤ 2;
- •Subject or legal representative is able to understand the purpose of study, agrees to comply with protocol requirements and has provided written informed consent.
排除标准
- •Chronic occlusion in the target area;
- •Epilepsy at the time of stroke；
- •Bleeding from the gastrointestinal or urinary system in the past three weeks；
- •After drug control, systolic blood pressure was greater than 185mmhg and / or diastolic blood pressure was greater than 110mmhg;
- •International Normalized Ratio(INR)>3;
- •Random blood glucose < 2.7mmol/L or > 22.2mmol/L;
- •Heart, lung, liver, kidney failure or other serious diseases (such as brain tumors, - systemic infection, active disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe mental illness);
- •Tortuous lesion / severe stenosis in the starting segment of the carotid artery / Carotid dissection / Arteritis judged by researchers that is not suitable for the procedure;
- •Acute occlusion of bilateral carotid arteries；
- •Intracranial hemorrhage or massive infarction diagnosed by CT or MR;
- •History of allergies to antiplatelet drugs, anticoagulants, anesthetics, contrast agents;
- •Expected life <12 months;
- •Female subjects who are pregnant or planning to become pregnant or lactate within the study period;
- •Subject has participated in any other drug or medical device clinical trials in 1 month before signing informed consent;
- •Other circumstances judged by researchers that are not suitable for enrollment .
结局指标
主要结局
Successful recanalization rate within three-times aspiration
时间窗: Up to 90 days
Successful recanalization is defined as modified Thrombolysis In Cerebral Infarction scale(mTICI) 2b or 3 evaluated by Digital subtraction angiography (DSA).
次要结局
- Device delivery performance(Intraoperation)
- Death rate(Up to 90 days)
- The rate of AE(Up to 90 days)
- The rate of SAE(Up to 90 days)
- Successful recanalization rate beyond three-times aspiration(Intraoperation)
- Rate of Modified Rankin Scale(mRS) score less than 3(90 days)
- Successful recanalization rate within three-times aspiration(Intraoperation)
- National Institute of Health stroke scale(NIHSS)(72 hours / 7 days)
- The rate of symptomatic intracranial hemorrhage(72 hours)
- The rate of medical device deficiency(Up to 90 days)
研究者
研究点 (15)
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