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Clinical trial of the CP stent for pulmonary artery stenosis: the first investigator-initiated clinical trial for pediatric interventional cardiology in Japan

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Abstract

Stenting is an important treatment option for pulmonary artery stenosis (PS) associated with congenital heart disease (CHD). However, no stent has been approved for this indication in Japan, despite negotiation between academia and the regulatory bodies for longer than 20 years. To evaluate efficacy and safety of the CP stent, we performed the first investigator-initiated clinical trial for pediatric interventional cardiology in Japan. This trial was designed as a single-arm, prospective, clinical trial. Patients who had postoperative PS associated with CHD were included. Stenting was attempted in 24 cases and succeeded in 22 cases. The median age of the patients was 11 years (3–36 years) and weight was 38 kg (12–69 kg), while follow-up for 12 months was completed. In all 22 cases, stenting was successful, with a 50% increase in the minimum lumen diameter (MLD) in 86.4% of patients (90% confidence interval, 68.4–96.2%). The mean percent change in MLD was 119.3 ± 52.5%. In two-ventricle repair, the mean percent change in systolic right ventricular/aortic pressure was − 8.5 ± 16.1%, while that of pressure gradient was − 55.9 ± 41.7%. In single-ventricle repair, the percent change in the mean pressure gradient was − 100.0 ± 0%, while that of SaO2 was 1.4 ± 1.7%. No serious adverse events or significant restenosis was reported. The CP stent is highly effective and safe for PS associated with CHD. This study has significant importance in not only scientific but also social considerations.

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Acknowledgements

This research is supported by the Project Promoting Clinical Trials for Development of New Drugs and Medical Devices (Japan Medical Association) from Japan Agency for Medical Research and Development, AMED. We thank Ellen Knapp, PhD, from Edanz Group (https://www.edanzediting.com/ac) for editing a draft of this manuscript.

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Authors and Affiliations

  1. Pediatric Heart Disease and Adult Congenital Heart Disease Center, Showa University Hospital, 1-5-8, Hatanodai, Shinagawa-Ku, Tokyo, 142-8666, Japan

    Takanari Fujii & Hideshi Tomita

  2. Department of Pediatric Cardiology, Saitama Medical University International Medical Center, Hidaka, Japan

    Toshiki Kobayashi

  3. Department of Pediatric Cardiology, National Center for Child Health and Development, Tokyo, Japan

    Hitoshi Kato

  4. Department of Pediatric Cardiology and Adult Congenital Cardiology, Tokyo Women’s Medical University, Tokyo, Japan

    Hisashi Sugiyama

  5. Department of Pediatrics, National Center for Global Health and Medicine, Tokyo, Japan

    Ayumi Mizukami

  6. Department of Cardiology, Kanagawa Children’s Medical Center, Yokohama, Japan

    Hideaki Ueda

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  1. Takanari Fujii
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  2. Hideshi Tomita
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  3. Toshiki Kobayashi
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  4. Hitoshi Kato
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  5. Hisashi Sugiyama
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  6. Ayumi Mizukami
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  7. Hideaki Ueda
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Correspondence to Takanari Fujii.

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Fujii, T., Tomita, H., Kobayashi, T. et al. Clinical trial of the CP stent for pulmonary artery stenosis: the first investigator-initiated clinical trial for pediatric interventional cardiology in Japan. Heart Vessels 36, 291–296 (2021). https://doi.org/10.1007/s00380-020-01691-0

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  • DOI: https://doi.org/10.1007/s00380-020-01691-0

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