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

NCT03210623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-09-12

No results posted yet for this study

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™.

Conditions

Interventions

DEVICE

stent retriever(TonbridgeMT)

mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)

DEVICE

Solitaire™

mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)

Sponsors & Collaborators

  • Guangzhou Osmunda Medical Device Technology, Inc., Ltd.

    collaborator INDUSTRY
  • Ton-Bridge Medical Tech. Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Jianmin Liu · Changhai Hospital of Shangha

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-03
Primary Completion
2018-08-27
Completion
2018-08-27

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03210623 on ClinicalTrials.gov