RT Journal Article
SR Electronic
T1 Comparing a novel Catfish flow restoration device and the Solitaire stent retriever for thrombectomy revascularisation in emergent largevessel occlusion stroke: a prospective randomised controlled study
JF Stroke and Vascular Neurology
JO Stroke Vasc Neurol
FD BMJ Publishing Group Ltd
SP 435
OP 443
DO 10.1136/svn-2022-002036
VO 8
IS 6
A1 Luo, Gang
A1 Yan, Xiaoyan
A1 Xiao, Guodong
A1 Wei, Liping
A1 Nai bi jiang, Ya li kun
A1 Ma, Rongyao
A1 Chen, Wenhuo
A1 Fang, Chun
A1 Zhou, Zhiming
A1 Wan, Jieqing
A1 Peng, Ya
A1 Zhang, Guilian
A1 Zhao, Junfeng
A1 Li, Li
A1 Yuan, Haicheng
A1 Wu, Jin
A1 Li, Bing
A1 Zhang, Fan
A1 Cheng, Yuhong
A1 Gao, Feng
A1 Miao, Zhongrong
YR 2023
UL http://svn.bmj.com/content/8/6/435.abstract
AB Background The Catfish stent retriever is a newly developed mechanical thrombectomy device for rapid recanalisation in emergent large vessel occlusion (ELVO) stroke. The current trial aimed to assess whether the Catfish stent retriever is non-inferior to the Solitaire stent retriever in terms of outcomes in ELVO stroke.Methods This was a randomised, prospective, parallel-group, multicentre, open-label, non-inferiority study conducted at 18 sites in China. The primary outcome was the proportion of cases with successful recanalisation (modified thrombolysis in cerebral infarction score of 2b or 3) following the procedure. Secondary efficacy outcomes included the National Institutes of Health Stroke Scale scores at 24 hours and 7 days or discharge if earlier, time from artery puncture to successful recanalisation and good clinical outcome (modified Rankin scale score ≤2) at 90 days. Safety outcomes included symptomatic intracranial haemorrhage, all cause-death and severe adverse events at 90 days.Results Between 3 March 2019 and 5 June 2021, 118 and 120 patients were randomly allocated to the Catfish and Solitaire groups, respectively. The primary endpoint after all endovascular procedures was non-inferior in the Catfish group (88.5%, 100/113) than in the Solitaire group (87.7%, 100/114), with a rate difference (RD) of 0.78% (95% CI –7.64 to –9.20; p=0.001). Sensitivity analysis only considering the per-protocol set also yielded similar results, with an RD of 0.83% (95% CI –7.03 to –8.70; p<0.001). Additionally, the proportions of cases with good clinical outcomes (47.8% vs 50.0%, p=0.739) and all-cause death rates (17.7% vs 18.8%, p=0.700) were similar in both groups at 90 days.Conclusions The Catfish stent retriever is an effective and safe device for endovascular recanalisation in ELVO stroke.Trial registration number NCT03820882.Data are available upon reasonable request.