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Clinical Trial 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™.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03210623
Study type Interventional
Source Zhuhai Tonbridge Medical Tech. Co., Ltd.
Contact
Status Completed
Phase N/A
Start date August 3, 2017
Completion date August 27, 2018

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