Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-01

Study Completion Date

2020-06-20

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Ischemic Stroke Acute Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A prospective, non-randomized, controlled, outcome-blinded study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention group

patients in this group will receive mechanical thrombectomy and standardized drug treatment of acute ischemic stroke

Group Type EXPERIMENTAL

Mechanical Thrombectomy

Intervention Type PROCEDURE

Solitaire stent and manual aspiration thrombectomy were performed as the first-line endovascular treatment

control group

patients in this group will receive standardized drug treatment of acute ischemic stroke

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mechanical Thrombectomy

Solitaire stent and manual aspiration thrombectomy were performed as the first-line endovascular treatment

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. age≥18 years old;
3. the NIHSS score before evaluation of thrombectomy\<6;
4. 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

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No