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临床试验/NCT05291637
NCT05291637已完成不适用

Endovascular Therapy vs Medical Management of PosterIor Cerebral Artery Occlusion Stroke

Boston Medical Center22 个研究点 分布在 7 个国家目标入组 1,282 人开始时间: 2022年1月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,282
试验地点
22
主要终点
Change in stroke outcome based on modified Rankin Scale (mRS)

研究概览

简要总结

For this retrospective study, the investigators will collect and analyze data of patients who presented with posterior artery occlusion and underwent mechanical thrombectomy (the type of endovascular stroke treatment) and intravenous thrombolysis (the type of non-endovascular stroke treatment).

The electronic health records will be queried for the demographic, medical history, and outcomes data of all patients with posterior cerebral artery occlusion who underwent mechanical thrombectomy, intravenous thrombolysis (IVT), or medical management.

详细描述

The primary aims of the research are to evaluate, in patients presenting with posterior artery occlusion (PCA), whether favorable outcome would be superior for EVT compared to Medically Management (MM), inclusive of intravenous thrombolysis (IVT), as measured by:

  • 90-day modified Rankin Scale (mRS) ordinal shift or
  • decrease in NIH Stroke Scale/Score (NIHSS) by two points at 24 hours or at hospital discharge

The secondary aims are to evaluate in patients presenting with PCA occlusion, other outcome and safety metrics:

  • 90-day functional independence, mRS 0-2
  • 90-day excellent outcome, mRS 0-1
  • Visual field recovery (none, partial, complete) by 90-days
  • rate of reperfusion by modified thrombolysis in cerebral infarction (TICI) scale grade
  • any intracranial hemorrhage
  • symptomatic intracranial hemorrhage
  • mortality

In subgroup analysis, the investigators aim to identify subgroups that may confer differential treatment benefit by:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Had an ischemic stroke with isolated posterior cerebral artery occlusion (P1, P2, or P3 segments) and was medically managed or managed with EVT during the study time period.

排除标准

  • Patient with documented basilar artery occlusion and concomitant PCA occlusion
  • Patient with documented basilar artery occlusion, migration with secondary PCA occlusion

结局指标

主要结局

Change in stroke outcome based on modified Rankin Scale (mRS)

时间窗: baseline, 90 days

The Modified Rankin Scale (mRS) assesses disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. Scores can range from 0-6, where 0 is no disability, 5 is disability requiring constant care for all needs, and 6 is death. For this outcome an ordinal shift analysis will be done, assessing all changes across the range from baseline at 90 days.

Change in NIH Stroke Score (NIHSS)

时间窗: baseline, 7 days

The NIH Stroke Scale/Score (NIHSS) is is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. Scores can range from 0 to 42 and higher scores are associated with more severe stroke: 1-4= Minor stroke, 5-15= Moderate stroke, 15-20= Moderate/severe stroke, and 21-42 =Severe stroke.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (22)

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