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
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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