Ischemic Stroke Clinical Trial
Official title:
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™.
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.
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