Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

Tongji University

Status: Completed

Conditions: Ischemic Stroke; Acute Stroke

Treatments: Procedure: Mechanical Thrombectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04526756

2016-DFNE-002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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105 participants in 2 patient groups

Intervention group

Experimental group

Description:

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

Treatment:

Procedure: Mechanical Thrombectomy

control group

No Intervention group

Description:

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