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  • 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

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New devices and techniques
Original research
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
  1. Tengfei Zhou1,2,
  2. Tianxiao Li1,
  3. Liangfu Zhu1,
  4. Zhaoshuo Li1,
  5. Qiang Li1,
  6. Wei-xing Bai1,
  7. Ying-kun He1,
  8. Xiao Liu1,
  9. Haitao Guan3,
  10. Youming Long4,
  11. Jinchao Liu5,
  12. Liping Wei6,
  13. Guangxian Nan7,
  14. Hongzhuang Li8,
  15. Changming Wen9,
  16. Yude Zhang10,
  17. Hongyu Qiao11,
  18. Jianfeng Han12,
  19. Shouchun Wang13,
  20. Jianping Gu14,
  21. Xueli Cai15,
  22. Sheng Liu16,
  23. Zhenxin Zhao17
  1. 1 Department of Cerebrovascular Disease, Henan Provincial People's Hospital, Zhengzhou, Henan, China
  2. 2 Zhengzhou University People's Hospital, Zhengzhou, China
  3. 3 The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China
  4. 4 Guangzhou Medical University Second Affiliated Hospital, Guangzhou, Guangdong, China
  5. 5 Puyang Oilfield General Hospital, Puyang, Henan, China
  6. 6 Luoyang Central Hospital, Luoyang, Henan, China
  7. 7 China-Japan Union Hospital of Jilin University, Changchun, Jilin, China
  8. 8 Shunde Hospital of Southern Medical University, Foshan, Guangzhou, China
  9. 9 Nanyang Central Hospital, Nanyang, Henan, China
  10. 10 Henan University of Science and Technology Affiliated First Hospital, Luoyang, Henan, China
  11. 11 Jinan University First Affiliated Hospital, Guangzhou, Guangdong, China
  12. 12 Xi'an Jiaotong University Medical College First Affiliated Hospital, Xi'an, Shaanxi, China
  13. 13 The First Affiliated Hospital of Jilin University, Changchun, China
  14. 14 Nanjing First Hospital, Nangjing, Jiangsu, China
  15. 15 Lishui Central Hospital and Fifth Affiliated Hospital of Wenzhou Medical College, Lishui, Zhejiang, China
  16. 16 Jiangsu Province Hospital and Nanjing Medical University First Affiliated Hospital, Nanjing, Jiangsu, China
  17. 17 Fudan University, Shanghai, Shanghai, China
  1. Correspondence to Dr Tianxiao Li, Department of Cerebrovascular Disease, Henan Provincial People's Hospital, Zhengzhou, Henan, China; litianxiao6666{at}126.com

Abstract

Background 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.

Methods 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.

Results 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.

Conclusion 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%).

  • stroke
  • thrombectomy
  • stent

Data availability statement

Data are available upon reasonable request. Not applicable.

https://doi.org/10.1136/neurintsurg-2021-018117

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    Data availability statement

    Data are available upon reasonable request. Not applicable.

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    Footnotes

    • Contributors TFZ, TXL, LFZ, ZSL, QL, XL, ZXZ and YKH designed the study. HTG, YML, JZL, LPW, GXN, HZL, CMW, YDZ, HYQ, JFH, SCW, JPG, XLC and TFZ conducted the trial and collected information. WXB and SL participated in the imaging evaluation. TFZ drafted the manuscript. All authors critically reviewed the manuscript and approved the final version. TXL acted as guarantor responsible for the overall content.

    • Funding Supported by grant of Technological Research Project of Henan Province (182102310162).

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.