None listed
Conditions
Brief summary
SICARIO-LC 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 between 70 and 100mL. Primary outcome will be the proportion of patients with modified Rankin Scale (mRS) 0-2 (no significant disability) at 3 months.
Interventions
SICARIO-LC will include patients presenting with a baseline perfusion core lesion volume between 70 and 100mL. Patients will be randomized to receive thrombectomy or not. The thrombectomy device and method used will be at the interventionalist's discretion.
The thrombolysis decision will be up to the treating physicians’ decision based on current local/regional best evidence guidelines. This will minimize the chances of selection bias as the research team members are not interfering in the cli
SICARIO-LC will include patients presenting with a baseline perfusion core lesion volume between 70 and 100mL. Patients will be randomized to receive thrombectomy or not. The thrombectomy device and method used will be at the interventionalist's discretion. The thrombolysis decision will be up to the treating physicians’ decision based on current local/regional best evidence guidelines. This will minimize the chances of selection bias as the research team members are not interfering in the clinician’s judgment. However, the research team will control the thrombolysis decision at the randomisation process to avoid any possible imbalances. 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 and carried out by the neurointerventionalist.
Sponsors
The University of Newcastle
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 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.
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.
Outcome results
None listed