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临床试验/NCT04526756
NCT04526756已完成不适用

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

Shanghai East Hospital1 个研究点 分布在 1 个国家目标入组 105 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
105
试验地点
1
主要终点
modified Rankin Scale(mRS) score of 0 to 2

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

modified Rankin Scale(mRS) score of 0 to 2

时间窗: 90 days

independent outcome at 90 days

次要结局

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

研究者

发起方
Shanghai East Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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