Department of Neurology, UT McGovern Medical School, Houston, USA.
Department of Neurology, Valley Baptist Medical Center, Harlingen, USA.
Int J Stroke. 2022 Jul;17(6):689-693. doi: 10.1177/17474930211035032. Epub 2021 Dec 15.
Randomized evidence for endovascular thrombectomy safety and efficacy in patients with large core strokes is lacking.
To demonstrate endovascular thrombectomy 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.
SELECT2 is a prospective, randomized, multi-center, assessor-blinded controlled trial with adaptive enrichment design, enrolling up to 560 patients.
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] ≥ 50 cc) will be randomized in a 1:1 ratio to undergo endovascular thrombectomy or medical management (MM) only up to 24 h of last known well.
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.
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.
The SELECT2 trial will evaluate endovascular thrombectomy safety and efficacy in large cores on either CT or perfusion imaging and may provide randomized evidence to extend endovascular thrombectomy eligibility to larger population. ClinicalTrials.gov-NCT03876457.
缺乏随机证据表明血管内血栓切除术在大核心梗死患者中的安全性和疗效。
证明非对比 CT 或灌注成像（CT/MR）上有大核心的患者血管内血栓切除术的疗效和安全性，并确定基于成像方式，大核心患者的治疗效果是否存在异质性。
SELECT2 是一项前瞻性、随机、多中心、评估者盲法对照试验，采用适应性富集设计，最多纳入 560 名患者。
符合临床标准且在前循环大血管闭塞，伴有大核心的患者（非对比 CT 上 ASPECTS 为 3-5 分，或灌注成像上 CTP [rCBF < 30%] 和/或 MRI [ADC < 620] ≥ 50 cc）将按 1:1 的比例随机分为血管内血栓切除术组或仅在发病后 24 小时内接受药物治疗（MM）组。
90 天 mRS 评分分布是主要结局。功能独立性（mRS=0-2）率是次要结局。其他次要结局包括安全性（症状性 ICH、神经恶化、死亡率）和影像学结局。
采用正态近似的 Wilcoxon-Mann-Whitney 检验（广义似然比检验）评估主要结局。还将比较功能独立性率、安全性和影像学结局。
SELECT2 试验将评估 CT 或灌注成像上有大核心的患者血管内血栓切除术的安全性和疗效，并可能提供随机证据，将血管内血栓切除术的适应证扩大到更大的人群。ClinicalTrials.gov-NCT03876457。
