Stroke in patients with Very large Ischaemic Core: Assessment of Reperfusion therapy Impact on Outcome (SICARIO-VLC)

Not Applicable

Recruiting

• Conditions: Acute Ischaemic Stroke; Stroke - Ischaemic

• Registration Number: ACTRN12622000880741
• Lead Sponsor: The University of Newcastle

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-21
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified