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临床试验/ACTRN12622000880741
ACTRN12622000880741招募中未知

Stroke in patients with Very large Ischaemic Core: Assessment of Reperfusion therapy Impact on disability Outcomes: SICARIO single arm trial on thrombectomy vs historical control.

The University of Newcastle0 个研究点目标入组 150 人开始时间: 2022年6月21日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Non-randomised trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Patients presenting with acute hemispheric ischemic stroke with onset (or the time last known to be well) within 24 hours.
  • Presence of a baseline ischemic core of >100 mL (SICARIO-VLC) on CT perfusion imaging or diffusion-perfusion MRI processed with automated perfusion volumetric analysis (MIStar - Apollo Medical Imaging-, being the preferred software for the trial due to less variability in its outputs).
  • Patient’s age is 18 years or above
  • Premorbid modified Rankin Scale score 0 to 2.
  • Presence of a large vessel occlusion on CTA or MRA.
  • Large vessel occlusion will be defined as a ‘potentially retrievable’ thrombus at one or more of the following sites: intracranial internal carotid (ICA), middle cerebral artery (MCA) first segment (M1) or combination of an extracranial segment of ICA and an intracranial occlusion (terminal ICA or MCA) -tandem occlusion-.
  • Onset of acute imaging to groin puncture (in the patients randomized to thrombectomy) under 120 minutes.

排除标准

  • Intracranial haemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.
  • Vertebro-basilar artery occlusion
  • Pre-stroke mRS > 2 (indicating significant previous disability)
  • Any terminal illness such that patient would not be expected to survive more than 1 year.
  • Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.
  • Pregnancy - women of childbearing age with a positive urine pregnancy test.

研究者

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