Background
Endovascular thrombectomy (EVT) is effective for large vessel occlusion (LVO) ischemic stroke patients with small volumes of computed tomography perfusion (CTP)-defined ischaemic core within 24 hours from onset. There is randomized clinical trial data available showing benefit of EVT for patients with large core >70mL, however most of the patients included had an ischemic core between 70 to 100mL. Whether patients with a baseline ischemic core >100mL can benefit from EVT is still an unanswered question. We propose a single arm open-label historical-controlled trial, using volumetric measures of very large core (>100 mL).
Methods
Design: SICARIO is a prospective, international, Bayesian Optimal Phase 2 trial designed to test the promise of effect of EVT on 3-month modified Rankin Scale (mRS), with objective performance criterion derived from the INSPIRE registry. (Sample size: up to 150 patients).
Population: Ischaemic stroke patients with anterior LVO within 24 hours of onset with an ischemic core of >100 mL and a premorbid mRS <3.
Primary Outcome: Proportion of patients with mRS 0-4 (no catastrophic outcome) at 3 months.
Conclusions
SICARIO trial started recruitment in Australia in November 2022, (three active sites at the time of submission) and it will start internationally in late 2024. Seven patients have been already enrolled into the trial.