Comparing the efficacy and safety of the Skyflow device with those of the Solitaire FR stent in patients with acute ischemic stroke: a prospective, multicenter, randomized, non-inferiority clinical trial

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
出处
期刊:Journal of NeuroInterventional Surgery [BMJ]
卷期号:14 (11): 1130-1134 被引量:5
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%).
最长约 10秒,即可获得该文献文件

科研通智能强力驱动
Strongly Powered by AbleSci AI
更新
大幅提高文件上传限制,最高150M (2024-4-1)

科研通是完全免费的文献互助平台,具备全网最快的应助速度,最高的求助完成率。 对每一个文献求助,科研通都将尽心尽力,给求助人一个满意的交代。
实时播报
西门吹雪9527完成签到,获得积分10
1秒前
Winnie完成签到 ,获得积分10
3秒前
4秒前
大个应助暴躁的信封采纳,获得10
7秒前
小木完成签到,获得积分10
8秒前
8秒前
9秒前
briliian发布了新的文献求助10
9秒前
语亦菲扬921完成签到,获得积分10
11秒前
SUPERDOUBLE完成签到,获得积分10
11秒前
11秒前
ZZDL发布了新的文献求助10
13秒前
Ava应助LVVVB采纳,获得10
14秒前
lxcy0612完成签到,获得积分10
14秒前
14秒前
SUPERDOUBLE发布了新的文献求助10
15秒前
Lqiang完成签到,获得积分10
15秒前
16秒前
16秒前
Singularity应助科研通管家采纳,获得10
17秒前
乐乐应助科研通管家采纳,获得10
17秒前
小牛应助科研通管家采纳,获得10
18秒前
丘比特应助科研通管家采纳,获得10
18秒前
Singularity应助科研通管家采纳,获得10
18秒前
大模型应助科研通管家采纳,获得10
18秒前
Lucas应助科研通管家采纳,获得10
18秒前
科研通AI2S应助科研通管家采纳,获得10
18秒前
领导范儿应助科研通管家采纳,获得10
18秒前
科研通AI2S应助科研通管家采纳,获得10
18秒前
18秒前
英俊的铭应助科研通管家采纳,获得10
18秒前
隐形曼青应助科研通管家采纳,获得10
18秒前
rainbow完成签到,获得积分20
19秒前
lshl2000发布了新的文献求助10
19秒前
Jasper应助明亮若枫采纳,获得10
21秒前
yml完成签到 ,获得积分10
21秒前
22秒前
领导范儿应助范米粒采纳,获得10
22秒前
24秒前
11完成签到,获得积分10
25秒前
高分求助中
Evolution 10000
Sustainability in Tides Chemistry 2800
The Young builders of New china : the visit of the delegation of the WFDY to the Chinese People's Republic 1000
юрские динозавры восточного забайкалья 800
English Wealden Fossils 700
Foreign Policy of the French Second Empire: A Bibliography 500
Chen Hansheng: China’s Last Romantic Revolutionary 500
热门求助领域 (近24小时)
化学 医学 生物 材料科学 工程类 有机化学 生物化学 物理 内科学 纳米技术 计算机科学 化学工程 复合材料 基因 遗传学 催化作用 物理化学 免疫学 量子力学 细胞生物学
热门帖子
关注 科研通微信公众号,转发送积分 3146272
求助须知:如何正确求助?哪些是违规求助? 2797641
关于积分的说明 7825012
捐赠科研通 2454032
什么是DOI,文献DOI怎么找? 1305957
科研通“疑难数据库(出版商)”最低求助积分说明 627630
版权声明 601503