Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)
The Efficacy and Safety Study of Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Beijing、中国
- The 306th Hospital of Chinese PLA
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Changchun、中国
- The First Hospital of Jilin University
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Changchun、中国
- China-Japan Union Hospital
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Changzhou、中国
- The First People's Hospital of Changzhou
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Guangzhou、中国
- The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
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Guiyang、中国
- The Affiliated Hospital of Guizhou Medical University
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Hangzhou、中国
- Hangzhou First People's Hospital
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Hanzhou、中国
- The second affiliated hospital of zhejiang university school of medicine
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Nanjing、中国
- Nanjing First Hospital Affiliated to Nanjing Medicine University
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Nanning、中国
- Nanning People's Hospital
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Wuhan、中国
- The Third People's Hospital of Hubei Province
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Xi'an、中国
- Tangdu Hospital
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Zhengzhou、中国
- Henan Provincial People's Hospital
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Zhengzhou、中国
- The First Affiliated Hospital of Zhengzhou University
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Zhongshan、中国
- Zhongshan People's Hospital
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Zhuhai、中国
- The Fifth Affiliated Hospital Sun Yat-Sen University
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Shanghai
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Shanghai、Shanghai、中国
- Changhai Hospital of Shanghai
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18≤ages≤80;
- Baseline NIHSS score obtained prior to randomization must be lower than 30 points;
- 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);
- 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;
- Pre-AIS mRS score lower than 2.
Exclusion Criteria:
- 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);
- DSA evidence of simultaneous acute bilateral carotid occlusion;
- DSA evidence of occlusions in the initial segment of carotid artery or carotid artery dissection or arteritis;
- DSA evidence of tortuosity of cervical vessels precluding device delivery/deployment;
- Hypertension (Systolic blood pressure(SBP)>185 mm Hg or diastolic blood pressure(DBP)>110 mm Hg) after using drug;
- Platelet count<40,000/μL and use of Novel Anticoagulant with International Normalized Ratio(INR)>3.0;
- Random blood glucose of<2.7mmol/L or>22.2mmol/L;
- 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);
- Patients who will not cooperate or tolerate interventional operation;
- Anticipated life expectancy of less than 90 days;
- Allergy to contrast medium;
- Females who are pregnant or breastfeeding;
- Participation in any other clinical trial within the past 1 months before screening and follow-up;
- The patient or the patient's legally authorized representative hasn't signed and dated an informed consent form;
- 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
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 |
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实验性的:group A
subjects applying the stent retriever(TonbridgeMT)
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mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
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有源比较器:group B
subjects applying Solitaire™
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mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
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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 |
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successful recanalization rate in patients
大体时间:intraoperative immediate
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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
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intraoperative immediate
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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successful recanalization rate in vessels
大体时间:intraoperative immediate
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The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
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intraoperative immediate
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Time to achieve recanalization
大体时间:intraoperative immediate
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The period from femoral artery puncture to successful recanalization
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intraoperative immediate
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NIHSS score
大体时间:baseline, 24±6d and 7±2d after operation
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National Institutes of Health Stroke Scale
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baseline, 24±6d and 7±2d after operation
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mRS score
大体时间:baseline, 90±14d after operation
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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.
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baseline, 90±14d after operation
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the ratio of mRS 0-2
大体时间:baseline, 90±14d after operation
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The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
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baseline, 90±14d after operation
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transportation performance
大体时间:intraoperative immediate
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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
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intraoperative immediate
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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stent retriever(TonbridgeMT)的临床试验
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University of California, Los AngelesNational Institute of Neurological Disorders and Stroke (NINDS)完全的
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Johns Hopkins University完全的