Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)
- Conditions
- Ischemic Stroke
- Interventions
- Device: Solitaire™Device: stent retriever(TonbridgeMT)
- Registration Number
- NCT03210623
- Lead Sponsor
- Zhuhai Tonbridge Medical Tech. Co., Ltd.
- Brief Summary
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™.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 220
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group B Solitaire™ subjects applying Solitaire™ group A stent retriever(TonbridgeMT) subjects applying the stent retriever(TonbridgeMT)
- Primary Outcome Measures
Name Time Method successful recanalization rate in patients 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
- Secondary Outcome Measures
Name Time Method successful recanalization rate in vessels intraoperative immediate The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
Time to achieve recanalization intraoperative immediate The period from femoral artery puncture to successful recanalization
NIHSS score baseline, 24±6d and 7±2d after operation National Institutes of Health Stroke Scale
mRS score 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.
the ratio of mRS 0-2 baseline, 90±14d after operation The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
transportation performance 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
Trial Locations
- Locations (17)
Zhongshan People's Hospital
🇨🇳Zhongshan, China
The Fifth Affiliated Hospital Sun Yat-sen University
🇨🇳Zhuhai, China
Changhai Hospital of Shanghai
🇨🇳Shanghai, Shanghai, China
The First Hospital of Jilin University
🇨🇳Changchun, China
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
🇨🇳Guangzhou, China
Nanning People's Hospital
🇨🇳Nanning, China
The First People's Hospital of Changzhou
🇨🇳Changzhou, China
China-Japan union hospital
🇨🇳Changchun, China
The Second Affiliated hospital of Zhejiang University School of Medicine
🇨🇳Hanzhou, China
The Third People's Hospital of Hubei Province
🇨🇳Wuhan, China
The 306th Hospital of Chinese PLA
🇨🇳Beijing, China
Hangzhou First People's Hospital
🇨🇳Hangzhou, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, China
The Affiliated Hospital of Guizhou Medical University
🇨🇳Guiyang, China
Tangdu Hospital
🇨🇳Xi'an, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, China
Nanjing First Hospital Affiliated to Nanjing Medicine University
🇨🇳Nanjing, China