Abstract
Introduction
Results of systematic reviews and studies evaluating treatment effects of cerebrovascular interventions on the prevalence of post‐stroke cognitive impairment vary likely due to heterogeneity in populations, sample size, variable treatment effect, and time and methods of cognitive examination. Like thrombolytic therapy, endovascular therapy (EVT) in large vessel occlusion (LVO) stroke is strongly associated with successful reperfusion, reduced mortality, and good clinical outcomes. Nevertheless, the effect of successful reperfusion after EVT on cognitive function remains unexplored.
Methods
Four hundred (400) patients aged 18–75 will be enrolled in the USA and outside USA clinical centers. The primary endpoint will be the association between successful reperfusion, defined as eTICI ≥ 2b50, and cognitive benefit, defined as delta Montreal Cognitive Assessment (MoCA) from 4 days to 180 days post‐EVT or MoCA ≥ 26 at 180 days post‐EVT. Secondary endpoints will include first pass successful revascularization, reduction in hypoperfusion volumes within 24 h, functional evaluations (NIHSS, mRS), MoCA and cognitive battery evaluations, and QOLs at various timepoints, baseline to 180 days 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 will include all‐cause mortality, symptomatic intracranial hemorrhage within 24 h, and device‐related serious 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‐existing cognitive impairment and/or dementia.
Results
More study details including the statistical analysis plan and study status will be discussed.
Conclusions
COGNITIVE is a very first multi‐center, post‐market, prospective, single‐arm EVT study to evaluate whether successful reperfusion with the Tigertriever device is associated with cognitive benefit in subjects with LVO. The study is a superiority design to evaluate whether Tigertriever treatment significantly reduces cognitive impairment.
