Supplementary Material for: A nationwide prospective registry of endovascular thrombectomy for extra-large ischemic stroke with large vessel occlusion (XL STROKE): rationale and design

Introduction： The role of endovascular thrombectomy (EVT) for acute extra-large ischemic stroke patients with large vessel occlusion (LVO) is uncertain. We aimed to explore the clinical and safety outcomes of medical management (MM) plus EVT (EVT group) versus MM alone (MM group) among acute extra-large ischemic stroke patients with LVO within 24 hours of last known well. Methods： XL STROKE (endovascular thrombectomy for extra-large ischemic stroke) is an investigator-initiated, nationwide, prospective registry with blinded end point assessment performed at approximately 60 sites in China, and will enroll up to 990 acute ischemic stroke patients within 24 hours of last known well. Imaging inclusion criteria are occlusion of the internal carotid artery, or the middle cerebral artery M1 or M2 segments, and Alberta Stroke Program Early Computed Tomography Score of 0 to 2 or an ischemic-core volume ≥85ml. All patients will be dichotomized into EVT group and MM group according to whether they received EVT or not. The primary outcome is the level of disability on the modified Rankin Scale at 90±14 days. Safety outcomes include symptomatic intracranial hemorrhage within 48 hours, and mortality at 90±14 days. Conclusion： Results from XL STROKE registry will provide constructive evidence of improved disability outcomes and safety with EVT for acute extra-large ischemic stroke patients with LVO within 24 hours of last known well. Trial registrations: ClinicalTrials.gov, NCT06210633

引言：血管内取栓术（endovascular thrombectomy, EVT）对于伴大血管闭塞（large vessel occlusion, LVO）的急性超大面积缺血性卒中患者的应用价值尚不明确。本研究旨在探讨发病至末次知晓正常状态24小时内的伴LVO的急性超大面积缺血性卒中患者中，药物治疗（medical management, MM）联合EVT（EVT组）与单纯药物治疗（MM组）的临床结局及安全性结局。
方法：XL STROKE（超大面积缺血性卒中血管内取栓术研究）是一项由研究者发起的全国性前瞻性登记研究，在中国约60家研究中心开展，采用盲法终点评估，计划纳入最多990例发病至末次知晓正常状态24小时内的急性缺血性卒中患者。影像学纳入标准为：颈内动脉、大脑中动脉M1或M2段闭塞，且阿尔伯塔卒中项目早期CT评分（Alberta Stroke Program Early Computed Tomography Score）为0~2分，或缺血核心体积≥85ml。所有患者将根据是否接受EVT被分为EVT组与MM组。主要结局为发病后90±14天时的改良Rankin量表（modified Rankin Scale）评分所反映的残疾程度。安全性结局包括48小时内症状性颅内出血，以及发病后90±14天时的死亡率。
结论：XL STROKE登记研究的结果将为发病至末次知晓正常状态24小时内的伴LVO的急性超大面积缺血性卒中患者应用EVT可改善残疾结局与安全性提供建设性证据。
试验注册：ClinicalTrials.gov，NCT06210633