纸牌密码算法
医学
临床终点
外科
冲程(发动机)
随机对照试验
支架
蛛网膜下腔出血
脑梗塞
闭塞
改良兰金量表
内科学
缺血
缺血性中风
机械工程
工程类
作者
Tengfei Zhou,Tianxiao Li,Liangfu Zhu,Zhaoshuo Li,Qiang Li,Weixing Bai,Yingkun He,Xiao Liu,Haitao Guan,Youming Long,Бо Лю,Liping Wei,Guangxian Nan,Hongzhuang Li,Changming Wen,Yude Zhang,Hongyu Qiao,Jianfeng Han,Shouchun Wang,Jianping Gu,Xueli Cai,Sheng Liu,Zhen-xin Zhao
标识
DOI:10.1136/neurintsurg-2021-018117
摘要
Mechanical thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in the anterior circulation. This trial aimed to indicate whether Skyflow, a new thrombectomy device, could achieve the same safety and efficacy as Solitaire FR in the treatment of AIS.This study was a prospective, multicenter, randomized, single blind, parallel, positive controlled, non-inferiority clinical trial. Patients with intracranial anterior circulation LVO within 8 hours from onset were included to receive thrombectomy treatment with either the Skyflow or Solitaire FR stent retriever. The primary endpoint was the rate of successful reperfusion (modified Treatment In Cerebral Infarction (mTICI) ≥2b) after the operation. The safety endpoints were the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage (SAH) at 24 hours after operation.A total of 95 and 97 patients were involved in the Skyflow group and Solitaire FR group, respectively. A successful reperfusion (mTICI ≥2b) was finally achieved in 84 (88.4%) patients in the Skyflow group and 80 (82.5%) patients in the Solitaire FR group. Skyflow was non-inferior to Solitaire FR in regard to the primary outcome, with the criterion of a non-inferiority margin of 12.5% (p=0.0002) after being adjusted for the combined center effect and the National Institutes of Health Stroke Scale (NIHSS) score. The rate of periprocedural sICH and SAH did not differ significantly between the two groups.Endovascular thrombectomy with the Skyflow stent retriever was non-inferior to Solitaire FR with regard to successful reperfusion in AIS due to LVO (with a pre-specified non-inferiority margin of 12.5%).
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