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Completed

NCT Number: NCT04526756

Mechanical Thrombectomy for Acute Large Vessel Occlusion Stroke With Mild Symptoms

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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Key information

Conditions

Ischemic Stroke Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gang Li

Shanghai, Shanghai Municipality, 200123, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical thrombectomy

Procedure

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

Primary outcomes

  1. modified Rankin Scale(mRS) score of 0 to 2

    Time frame: 90 days

    independent outcome at 90 days

Secondary outcomes

  1. modified Rankin Scale(mRS) score of 0 to 1

    Time frame: 90 days

    excellent outcome at 90 days

Other outcomes

  1. Symptomatic intracranial haemorrhage transformation

    Time frame: 36 hours

    Symptomatic intracranial haemorrhage (sICH) transformation was defined according to European Cooperative Acute Stroke Study (ECASS)-III criteria

Sponsors and collaborators

Lead sponsor

Shanghai East Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Aug 26, 2020
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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