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
Inclusion Criteria7
- 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 Criteria6
- 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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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