Liu Huan, Li Zhaoshuo, Zhu Liangfu, Zhou Tengfei, Wu Qiaowei, He Yanyan, Song Xintong, He Yingkun, Li Tianxiao
Department of Interventional Neuroradiology, Zhengzhou University People's Hospital, Henan University People's Hospital, Henan Provincial People's Hospital, Henan Provincial Neurointerventional Engineering Research Center, Henan International Joint Laboratory of Cerebrovascular Disease and Henan Engineering Research Center of Cerebrovascular Intervention, Zhengzhou, China.
Norman Bethune College of Medicine, Jilin University, Changchun, China.
Front Neurol. 2021 Apr 30;12:645431. doi: 10.3389/fneur.2021.645431. eCollection 2021.
Stent retriever thrombectomy is the standard treatment for acute ischemic stroke (AIS) with large vessel occlusion (LVO) in anterior circulation. The aim of the trial is to evaluate whether the new thrombectomy device-Skyflow can achieve the same safety and efficacy as Solitaire FR in the treatment. This study is a prospective, multicenter, stratified randomized, single blind, paralleled, positive controlled, non-inferiority clinical trial. The safety and efficacy of vascular recanalization in AIS patients who are treated with either a new thrombectomy device-Skyflow or with Solitaire FR and within 8 h of symptom onset will be compared. A total of 192 patients will be enrolled, each group with 96 patients. The primary endpoint is successful recanalization rate after the operation. The secondary efficacy endpoints are the time from artery puncture to successful recanalization (mTICI 2b-3), NIHSS scores of 24 h (18-36 h), and 7 ± 2 days after the operation, mRS scores, and the rate of patients with mRS 0-2 scores 90 ± 14 days after the operation, and the success rate of instrument operation. The safety endpoints are the rate of symptomatic intracranial hemorrhage (sICH) and subarachnoid hemorrhage at 24 h (18-36 h) post-operation, incidence of adverse events (AE) and serious adverse events (SAE), all-cause mortality, and incidence of device defects. This trial will provide information on the safety and efficacy of Sky-flow stent retriever in the treatment of AIS patients with anterior circulation LVO. The success of this trial will be the basis for the product to be finally officially listed and applied in China. Registered on 11 March 2018 with Chinese clinical trial registry. Registration number is ChiCTR1800015166.
支架取栓术是治疗前循环大血管闭塞（LVO）急性缺血性卒中（AIS）的标准治疗方法。该试验的目的是评估新型取栓装置Skyflow在治疗中是否能达到与Solitaire FR相同的安全性和有效性。本研究是一项前瞻性、多中心、分层随机、单盲、平行、阳性对照、非劣效性临床试验。将比较在症状发作8小时内接受新型取栓装置Skyflow或Solitaire FR治疗的AIS患者血管再通的安全性和有效性。总共将招募192例患者，每组96例。主要终点是术后成功再通率。次要疗效终点是从动脉穿刺到成功再通的时间（mTICI 2b-3）、术后24小时（18-36小时）和7±2天的美国国立卫生研究院卒中量表（NIHSS）评分、改良Rankin量表（mRS）评分、术后90±14天mRS 0-2评分患者的比例以及器械操作成功率。安全终点是术后24小时（18-36小时）有症状颅内出血（sICH）和蛛网膜下腔出血的发生率、不良事件（AE）和严重不良事件（SAE）的发生率、全因死亡率以及器械缺陷发生率。该试验将提供Sky-flow支架取栓器治疗前循环LVO的AIS患者的安全性和有效性信息。该试验的成功将为该产品最终在中国正式上市和应用奠定基础。于2018年3月11日在中国临床试验注册中心注册。注册号为ChiCTR1800015166。
