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EXPRESS: A Randomized Controlled Trial to Optimize Patientas Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT2): Study Protocol.

EXPRESS: A Randomized Controlled Trial to Optimize Patientas Selection for Endovascular Treatment in Acute Ischemic Stroke (SELECT2): Study Protocol. International journal of stroke : official journal of the International Stroke Society Sarraj, A., Hassan, A. E., Abraham, M., Ribo, M., Blackburn, S., Chen, M., Hussain, M. S., Pereira, V. M., Ortega, S., Sitton, C., Lavori, P. W., Cai, C., Rahbar, M. H., Pujara, D. K., Shaker, F., Lansberg, M. G., Campbell, B., Grotta, J. C., Albers, G. W. 2021: 17474930211035032

Abstract

RATIONALE: Randomized evidence for endovascular thrombectomy(EVT) safety and efficacy in patients with large core strokes is lacking.AIMS: To demonstrate EVT efficacy and safety in patients with large core on non-contrast CT or perfusion imaging(CT/MR) and determine if there is heterogeneity of treatment effect in large cores based on the imaging modality.DESIGN: SELECT2 is a prospective, randomized, multi-center, assessor-blinded controlled trial with adaptive enrichment design, enrolling up to 560 patients.PROCEDURE: Patients who meet the clinical criteria and have anterior circulation large vessel occlusions with large core on either NCCT(ASPECTS 3-5) or perfusion imaging(CTP[rCBF<30%] and/or MRI[ADC <620]a50cc) will be randomized in a 1:1 ratio to undergo EVT or medical management(MM) only up to 24 hours of last known well.STUDY OUTCOMES: The distribution of 90-day mRS scores is the primary outcome. Functional independence(mRS=0-2) rate is a secondary outcome. Other secondary outcomes include safety(symptomatic ICH, neurological worsening, mortality) and imaging outcomes.ANALYSIS: A normal approximation of the Wilcoxon-Mann-Whitney test(the generalized likelihood ratio test) to assess the primary outcome. Functional independence rates, safety and imaging outcomes will also be compared.DISCUSSION: The SELECT2 trial will evaluate EVT safety and efficacy in large cores on either CT or perfusion imaging and may provide randomized evidence to extend EVT eligibility to larger population. Registration: ClinicalTrials.govaNCT03876457.

View details for DOI 10.1177/17474930211035032

View details for PubMedID 34282987