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Intracranial Thrombosis Aspiration Catheter for Recanalization in Acute Ischemic Stroke Therapy (RECOVER)

NCT03753061 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2019-09-19

No results posted yet for this study

Summary

This study is a prospective, multi-center, open-label, end-point blinded, randomized, parallel positive control, non-inferiority clinical trial, with a purpose to evaluate the safety and efficacy of Hemo Jirui intracranial thrombus aspiration catheter system for endovascular treatment of acute ischemic stroke by comparison with stent retriever (Solitaire FR). The trial is anticipated to last from November 2018 to May 2019, with 204 subjects recruited from 15-20 clinical trial centers in China.

Conditions

  • Large Vessel Occlusion
  • Acute Ischemic Stroke
  • Cerebrovascular Disorders

Interventions

DEVICE

Aspiration Catheter

Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.

DEVICE

Solitaire FR

Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.

Sponsors & Collaborators

  • Ministry of Science and Technology of the People´s Republic of China

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-22
Primary Completion
2020-03-20
Completion
2020-03-20

Countries

  • China

Study Locations

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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 NCT03753061 on ClinicalTrials.gov