Stent Retriever's(TonbridgeMT) Endovascular Therapy for Acute Ischemic Stroke(AIS)

Not yet recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Stent retriever(TonbridgeMT) Device
    Intervention Desc: mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
    ARM 1: Kind: Experimental
    Label: group A
    Description: subjects applying the stent retriever(TonbridgeMT)
  • Solitaire™ Device
    Intervention Desc: mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
    ARM 1: Kind: Experimental
    Label: group B
    Description: subjects applying Solitaire™

Outcomes

Type Measure Time Frame Safety Issue
Primary successful recanalization rate in patients during operation
Secondary successful recanalization rate in vessels during operation
Secondary Time to achieve recanalization during operation
Secondary NIHSS score baseline, 24±6d and 7±2d after operation
Secondary mRS score baseline, 90±14d after operation
Secondary the ratio of mRS 0-2 baseline, 90±14d after operation
Secondary transportation performance during operation

Sponsors