Abstract 358: The COGNITIVE study: Cognition and Imaging with Tigertriever

Introduction Results of systematic reviews and studies evaluating treatment effects of cerebrovascularinterventions on the prevalence of post‐stroke cognitive impairment vary likely due to heterogeneity inpopulations, sample size, variable treatment effect, and time and methods of cognitive examination. Likethrombolytic therapy, endovascular therapy (EVT) in large vessel occlusion (LVO) stroke is stronglyassociated with successful reperfusion, reduced mortality, and good clinical outcomes. Nevertheless, theeffect of successful reperfusion after EVT on cognitive function remains unexplored. Objective COGNITIVE is a very first multi‐center, post‐market, prospective, single‐arm EVT study toevaluate whether successful reperfusion with the Tigertriever device is associated with cognitive benefitin subjects with LVO. The study is a superiority design to evaluate whether Tigertriever treatmentsignificantly reduces cognitive impairment. Methodology Four hundred (400) patients aged 18‐75 will be enrolled in the USA and outside USAclinical centers. The primary endpoint will be the association between successful reperfusion, defined aseTICI ≥2b50, and cognitive benefit, defined as delta Montreal Cognitive Assessment (MoCA) from 4 daysto 180 days post‐EVT or MoCA ≥26 at 180 days post‐EVT. Secondary endpoints will include first passsuccessful revascularization, reduction in hypoperfusion volumes within 24 h, functional evaluations(NIHSS, mRS), MoCA and cognitive battery evaluations, and QOLs at various timepoints, baseline to 180days post‐EVT. The correlation between cognitive function and stroke characteristics, imaging variables,functional ability, and demographic and socio‐behavioral factors will be explored. Safety endpoints willinclude all‐cause mortality, symptomatic intracranial hemorrhage within 24 h, and device‐relatedserious adverse events. Key inclusion criteria are per instructions for use (IFU) and pre‐stroke mRS ≤1.Key exclusion criteria are per IFU, prior hemorrhage or stroke within 3 months, and pre‐existingcognitive impairment and/or dementia. Results to date, 13 patients were enrolled in three clinical centers with a mean age of 58 years (54% F).More study details including the statistical analysis plan and study status will be discussed. Conclusions This on‐going first large prospective study can potentially shed the light on the short andlong term relationships between reperfusion and stroke related cognitive impairment.