Stroke in patients with large Ischaemic Core: Assessment of Reperfusion therapy Impact on disability Outcomes: SICARIO Phase II randomised controlled trial on thrombectomy vs standard care.

The University of Newcastle0 个研究点目标入组 180 人开始时间: 2022年6月8日最近更新: 2023年9月26日

试验速览

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•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 70-100 mL on CT perfusion imaging or diffusion-perfusion MRI processed with automated perfusion volumetric analysis (MIStar - Apollo Medical Imaging specified as the preferred software for the trial aiming to reduce volume estimation variability).
•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.

•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.

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