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™.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
220
mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
Changhai Hospital of Shanghai
Shanghai, Shanghai Municipality, China
The 306th Hospital of Chinese PLA
Beijing, China
successful recanalization rate in patients
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
Time frame: intraoperative immediate
successful recanalization rate in vessels
The proportion of successful recanalized vessels in all targeted vessels which receive the stent retriever treatment
Time frame: intraoperative immediate
Time to achieve recanalization
The period from femoral artery puncture to successful recanalization
Time frame: intraoperative immediate
NIHSS score
National Institutes of Health Stroke Scale
Time frame: baseline, 24±6d and 7±2d after operation
mRS score
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.
Time frame: baseline, 90±14d after operation
the ratio of mRS 0-2
The proportion of patients who got a mRS 0-2 in patients who receive stent retriever treatment
Time frame: baseline, 90±14d after operation
transportation performance
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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China-Japan union hospital
Changchun, China
The First Hospital of Jilin University
Changchun, China
The First People's Hospital of Changzhou
Changzhou, China
The Second Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, China
Hangzhou First People's Hospital
Hangzhou, China
The Second Affiliated hospital of Zhejiang University School of Medicine
Hanzhou, China
Nanjing First Hospital Affiliated to Nanjing Medicine University
Nanjing, China
...and 7 more locations
Time frame: intraoperative immediate