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New devices and techniques
Original research
First-in-human experience of sirolimus coated balloon for symptomatic intracranial artery stenosis
  1. Jichang Luo1,2,
  2. Renjie Yang1,2,
  3. Tao Wang1,2,
  4. Jian Chen1,2,
  5. Xia Lu1,2,
  6. Bin Yang1,2,
  7. Peng Gao1,2,3,
  8. Yabing Wang1,2,
  9. Yanfei Chen1,2,
  10. Adam A Dmytriw4,5,
  11. Jiamin Zheng4,
  12. Robert W Regenhardt5,
  13. Zheng Li6,
  14. Han Xu7,
  15. Yan Ma1,2,
  16. Jonathon Zhao6,
  17. Liqun Jiao1,2
  1. 1Department of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China
  2. 2China International Neuroscience Institute (China-INI), Beijing, China
  3. 3Interventional Neuroradiology, Xuanwu Hospital Capital Medical University, Beijing, China
  4. 4Neurointerventional Program, Departments of Medical Imaging & Clinical Neurological Sciences, London Health Sciences Centre, Western University, London, Ontario, Canada
  5. 5Neuroendovascular Program, Massachusetts General Hospital & Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA
  6. 6Zylox-Tonbridge Medical Technology, HangZhou, ZheJiang, China
  7. 7R&D Center, Zylox-Tonbridge Medical Technology, Hangzhou, Zhejiang, China
  1. Correspondence to Dr Liqun Jiao, Department of Neurosurgery, Xuanwu Hospital Capital Medical University, Beijing, China; liqunjiao{at}sina.cn; Jonathon Zhao, Zylox-Tonbridge Medical Technology, Inc. No. 270, Shuyun Road, Hangzhou, Zhejiang, 311121, China; Jon.zhao{at}zyloxmedical.com

Abstract

Background The drug coated balloon is a promising endovascular therapy for intracranial atherosclerosis (ICAS), potentially combining the advantages of primary angioplasty and antiproliferative drugs. Previous studies have focused on the paclitaxel coated balloon, revealing promising outcomes in the treatment of ICAS, while concerns about the neurotoxicity of paclitaxel were reported. Sirolimus was shown to have less neurotoxicity in the canine cerebral vasculature. The feasibility and safety of a sirolimus coated balloon (SCB) for ICAS have never been evaluated in humans. We assessed the first-in-human feasibility and safety of SCBs for treating symptomatic patients with severe ICAS.

Methods This prospective, open label, single arm cohort study was designed to enroll patients with transient ischemic attacks or non-disabling, non-perforator territory ischemic stroke caused by severe ICAS (70–99%) and following at least 3 weeks after the onset of ischemic symptoms. The primary outcome was stroke or death within 30 days. All patients were followed up to detect restenosis at 6 months.

Results A total of 60 eligible patients were enrolled with an average age of 59.4±10.8 years. The technical success rate of SCBs for ICAS was 100%. Seven patients (11.7%) required stenting because of flow limited dissections or elastic retraction. Three patients (5.0%) had 30 day strokes, including two ischemic strokes and one hemorrhagic stroke. An additional three patients had recurrent stroke or death during follow-up. Ten patients had restenosis but only two had symptoms.

Conclusions SCBs may be feasible and safe in selected patients with symptomatic ICAS, with high grade stenosis (70–99%). Further studies are warranted.

  • Intracranial atherosclerosis
  • Drug-coated balloon
  • Sirolimus
  • Stroke
  • Severe stenosis

Data availability statement

Data are available upon reasonable request.

https://doi.org/10.1136/jnis-2023-021177

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    Data availability statement

    Data are available upon reasonable request.

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    Footnotes

    • Twitter @LouisXia, @AdamDmytriw

    • JL and RY contributed equally.

    • Contributors Concept and design: LJ and YM. Drafting of the manuscript: JL, RY, and TW. Critical revision of the manuscript for important intellectual content: XL and AAD. Statistical analysis: RWR and JZ. Obtained funding: JZ, ZL, and HX. Supervision: JC, BY, PG, YW, and YC. Responsible for the overall content: LJ and JZ

    • Funding This work was funded by Zylox-Tonbridge Medical Technology. The funding source had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of manuscript; and decision to submit the manuscript for publication.

    • Competing interests JZ is the funder and significant shareholder of Z-T Medical Technology. ZL and HX are product engineers at Z-T Medical Technology and served on advisory boards.

    • 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.