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Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)

2018年9月10日 更新者:Zhuhai Tonbridge Medical Tech. Co., Ltd.

The Efficacy and Safety Study of Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke

The study is a prospective, multi-center, stratified randomized, single-blind, parallel assignment, active control, non-inferiority trial. Patients are randomized 1 : 1 to either stent retriever(TonbridgeMT) or Solitaire™ for endovascular therapy for AIS. The study aims to evaluate the benefit and safety of stent retriever(TonbridgeMT) for AIS therapy, as compared to Solitaire™.

研究概览

详细说明

The main objective is to determine whether stent retriever(TonbridgeMT) will have non-inferior successful recanalization rate compared to Solitaire™ when applied to endovascular therapy for AIS.

The secondary objectives is to verify whether there isn't significant differences in time to achieve recanalization, NIHSS score, mRS score, and transportation performance between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.

The third objectives is to verify whether there isn't significant differences in the rate of symptomatic intracranial hemorrhage, subarachnoid hemorrhage, adverse event(AE), serious adverse event(SAE), actual condition of AE and device deficiencies between stent retriever(TonbridgeMT) and Solitaire™ when applied to endovascular therapy for AIS.

研究类型

介入性

注册 (实际的)

220

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Beijing、中国
        • The 306th Hospital of Chinese PLA
      • Changchun、中国
        • The First Hospital of Jilin University
      • Changchun、中国
        • China-Japan Union Hospital
      • Changzhou、中国
        • The First People's Hospital of Changzhou
      • Guangzhou、中国
        • The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
      • Guiyang、中国
        • The Affiliated Hospital of Guizhou Medical University
      • Hangzhou、中国
        • Hangzhou First People's Hospital
      • Hanzhou、中国
        • The second affiliated hospital of zhejiang university school of medicine
      • Nanjing、中国
        • Nanjing First Hospital Affiliated to Nanjing Medicine University
      • Nanning、中国
        • Nanning People's Hospital
      • Wuhan、中国
        • The Third People's Hospital of Hubei Province
      • Xi'an、中国
        • Tangdu Hospital
      • Zhengzhou、中国
        • Henan Provincial People's Hospital
      • Zhengzhou、中国
        • The First Affiliated Hospital of Zhengzhou University
      • Zhongshan、中国
        • Zhongshan People's Hospital
      • Zhuhai、中国
        • The Fifth Affiliated Hospital Sun Yat-Sen University
    • Shanghai
      • Shanghai、Shanghai、中国
        • Changhai Hospital of Shanghai

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. 18≤ages≤80;
  2. Baseline NIHSS score obtained prior to randomization must be lower than 30 points;
  3. Acute occlusion(TICI 0-1) of the intracranial segment of internal carotid artery(ICA), or M1/M2 middle cerebral artery(MCA), or A1/A2 anterior cerebral artery(ACA), as evidenced by digital subtraction angiography(DSA);
  4. Patient treatable within 6 hours of symptom onset(symptoms onset is defined as point in time the patient was last seen well (at baseline)) can accept the complete femoral artery puncture;
  5. Pre-AIS mRS score lower than 2.

Exclusion Criteria:

  1. Computed tomography (CT) or magnetic resonance imaging (MRI) evidence of intracranial hemorrhage or massive cerebral infarction (ASPECTS score of<6 or infarct volume≥70ml or volume>1/3 blood supplying areas of MCA on CT/diffusion weighted imaging(DWI);
  2. DSA evidence of simultaneous acute bilateral carotid occlusion;
  3. DSA evidence of occlusions in the initial segment of carotid artery or carotid artery dissection or arteritis;
  4. DSA evidence of tortuosity of cervical vessels precluding device delivery/deployment;
  5. Hypertension (Systolic blood pressure(SBP)>185 mm Hg or diastolic blood pressure(DBP)>110 mm Hg) after using drug;
  6. Platelet count<40,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)>3.0;
  7. Random blood glucose of<2.7mmol/L or>22.2mmol/L;
  8. Patients with heart or lung or liver or renal failure or other sever disease(intracranial tumors, cerebral arteriovenous malformation (AVM), systemic infection, active disseminated intravascular coagulation, myocardial infarction within the past 12 months before enrollment, history of sever psychosis);
  9. Patients who will not cooperate or tolerate interventional operation;
  10. Anticipated life expectancy of less than 90 days;
  11. Allergy to contrast medium;
  12. Females who are pregnant or breastfeeding;
  13. Participation in any other clinical trial within the past 1 months before screening and follow-up;
  14. The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
  15. Other factors that would cause harm or increased risk to the participant or close contacts, or preclude the participant's full adherence as per investigator's judgement.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:group A
subjects applying the stent retriever(TonbridgeMT)
mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
有源比较器:group B
subjects applying Solitaire™
mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
successful recanalization rate in patients
大体时间:intraoperative immediate
Successful recanalization is defined as modified Thrombolysis In Cerebral Ischemia scale 2b or 3. And it is evaluated by DSA intraoperative immediately in both treatment groups
intraoperative immediate

次要结果测量

结果测量
措施说明
大体时间
successful recanalization rate in vessels
大体时间:intraoperative immediate
The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
intraoperative immediate
Time to achieve recanalization
大体时间:intraoperative immediate
The period from femoral artery puncture to successful recanalization
intraoperative immediate
NIHSS score
大体时间:baseline, 24±6d and 7±2d after operation
National Institutes of Health Stroke Scale
baseline, 24±6d and 7±2d after operation
mRS score
大体时间:baseline, 90±14d after operation
The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.
baseline, 90±14d after operation
the ratio of mRS 0-2
大体时间:baseline, 90±14d after operation
The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
baseline, 90±14d after operation
transportation performance
大体时间:intraoperative immediate
The proportion of stent retriever which can push and draw back well during the operation. The operator will grade each stent retriever at four level, namely great, good, average,and bad
intraoperative immediate

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年8月3日

初级完成 (实际的)

2018年8月27日

研究完成 (实际的)

2018年8月27日

研究注册日期

首次提交

2017年7月2日

首先提交符合 QC 标准的

2017年7月4日

首次发布 (实际的)

2017年7月7日

研究记录更新

最后更新发布 (实际的)

2018年9月12日

上次提交的符合 QC 标准的更新

2018年9月10日

最后验证

2017年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

stent retriever(TonbridgeMT)的临床试验

3
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