Stroke in patients with Very large Ischaemic Core: Assessment of Reperfusion therapy Impact on Outcome (SICARIO-VLC)
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 Newcastle
150 participants
Nov 29, 2022
Interventional
Conditions
Summary
SICARIO-VLC is designed to test the effect of endovascular thrombectomy (with or without thrombolysis) on three-month functional outcomes in the population defined by the size of baseline perfusion core lesion volume above 100mL. Primary outcome will be the proportion of patients with modified Rankin Scale (mRS) 0-4 (no catastrophic outcome) at 3 months.
Eligibility
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Interventions
SICARIO-VLC will include patients presenting with a baseline perfusion core lesion >100mL and will be allocated to receive thrombectomy. The device used will be at the proceduralist’s discretion. The thrombolysis decision will be up to the treating physicians’ decision. This will minimize the chances of selection bias as the research team members are not interfering in the clinician’s judgment. Two types of standard of care clot retrieval devices used. (brands may vary between countries) 1. Stent retrievers such as Trevo by Stryker, Solitaire by Medtronic. 2. Aspiration catheters such as Penumbra Duration of thrombectomy procedure depends on complexity, approximately 1-2 hours. Procedure to be initiated within 2 hours of presentation as per protocol, performed by the neurointerventionalist.
Locations(14)
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ACTRN12622000880741