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Clinical Trials/NCT04526756
NCT04526756
Completed
Not Applicable

Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms After Imaging Selection

Shanghai East Hospital1 site in 1 country105 target enrollmentJuly 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ischemic Stroke
Sponsor
Shanghai East Hospital
Enrollment
105
Locations
1
Primary Endpoint
modified Rankin Scale(mRS) score of 0 to 2
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

Mechanical thrombectomy(MT) has been recommended in patients with acute large vessel occlusion stroke(LVO) , especially for those with National Institutes of Health Stroke Scale (NIHSS) score ≥6. However, it is still unclear if patients with minor strokes and LVO also benefit from MT.The aim of this study was to evaluate the safety and efficacy of MT for acute LVO and mild symptoms.

Detailed Description

This is a prospective cohort study of patients with with mild ischemic stroke (NIHSS Score \<6) and LVO. Patients were divided into 2 groups: MT or medical management.Baseline data and clinical outcomes were compared. A independent clinical outcome was defined as a modified Rankin Scale score of 0 to 2 at 90 days. A excellent clinical outcome was defined as a modified Rankin Scale score of 0 to 1 at 90 days. Symptomatic intracranial hemorrhage(sICH) was the safety outcome.

Registry
clinicaltrials.gov
Start Date
July 1, 2016
End Date
June 20, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Shanghai East Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • acute ischemic stroke within 24 hours of symptom onset presenting cortical symptoms (such as aphasia, somnolence,slow-minded,etc.) or vertigo with bilateral pathological signs;
  • age≥18 years old;
  • the NIHSS score before evaluation of thrombectomy\<6;
  • large artery occlusion including Middle cerebral artery M1, proximal M2 segment, intracranial internal carotid artery and infarct core volume≤50ml and mismatch ratio\>1.8 or basilar artery and posterior cerebral artery P1 occlusion

Exclusion Criteria

  • Patients without prior functional independence (mRS score of \>2)
  • Patients in intervention group with occlusive artery spontaneous recanalization in digital subtraction angiography
  • patients in control group with neurological worsening and received rescue thrombectomy

Outcomes

Primary Outcomes

modified Rankin Scale(mRS) score of 0 to 2

Time Frame: 90 days

independent outcome at 90 days

Secondary Outcomes

  • modified Rankin Scale(mRS) score of 0 to 1(90 days)

Study Sites (1)

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