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Efficacy of optical frequency domain imaging in detecting peripheral artery disease: the result of a multi-center, open-label, single-arm study

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Abstract

Optical frequency domain imaging (OFDI) is a high-resolution intracoronary imaging modality with fast automated longitudinal pullback. We aimed to evaluate the ability of performing OFDI from the superficial femoral artery (SFA) to the below-knee (BK) artery. This clinical trial was a multi-center, single-arm, open-label study. The primary endpoint was to obtain a clear image of the intra-vascular lumen from the SFA to the BK artery, specifically  > 270° visualization of the blood vessel lumen with  > 16/21 cross sections. The proportion of the clear image (≥ 85%) was regarded as confirmatory of the ability of OFDI to visualize the vessel lumen. Overall, 20 patients were enrolled. The proportion of the primary endpoint was 90% (18/20), and the pre-specified criterion was successfully attained. The proportion of the clear image assessed by the operator was 100% (20/20), and an additional statistical analysis for the proportion of the visualization,  > 270°, of the blood vessel lumen revealed a significantly higher cut-off value than that for the pre-specified criterion, 85% (p = 0.0315). There were three adverse events not related to OFDI. OFDI achieved acceptable visualization of the vessel lumen without any adverse event related to it. After regulatory approval based on the present study, OFDI will be available as a new option of endovascular imaging for peripheral artery diseases in daily practice

Trial registration: This study was registered in the Japanese Registry of Clinical Trials (jRCT 2052190025, https://jrct.niph.go.jp/latest-detail/jRCT2052190025).

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Abbreviations

BK:

Below knee

EVT:

Endovascular treatment

GCP:

Good clinical practice

IVUS:

Intra-vascular ultrasonography

jRCT:

Japanese Registry of Clinical Trials

MHLW:

Ministry of Health, Labor and Welfare

OCT:

Optical coherence tomography

OFDI:

Optical frequency domain imaging

PAD:

Peripheral artery diseases

PCI:

Percutaneous coronary intervention

PMDA:

Pharmaceuticals and Medical Devices Agency

SFA:

Superficial femoral artery

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Acknowledgements

We are grateful to all of the staff involved in this clinical study.

Funding

This study project was funded by the Terumo Corporation and supported by the Kobe Clinical and Translational Research Center.

Author information

Author notes

  1. Hiroyuki Kawamori and Akihide Konishi contributed equally to this work.

Authors and Affiliations

  1. Division of Cardiovascular Medicine, Department of Internal Medicine, Graduate School of Medicine, Kobe University, Kobe, Japan

    Hiroyuki Kawamori, Akihide Konishi, Toshiro Shinke, Hiromasa Otake, Takayoshi Toba, Shinsuke Nakano, Kosuke Tanimura & Ken-ichi Hirata

  2. Clinical and Translational Research Center, Kobe University Hospital, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan

    Akihide Konishi, Isao Nanba, Yasumasa Kakei & Takashi Omori

  3. Division of Cardiovascular Medicine, School of Medicine, Showa University, Shinagawa, Japan

    Toshiro Shinke & Hiroaki Tsujita

  4. Department of Cardiovascular and Renal Medicine, Hyogo College of Medicine, Nishinomiya, Japan

    Hirokuni Akahori & Masaharu Ishihara

  5. Hyogo Prefectural Himeji Cardiovascular Center, Himeji, Japan

    Yoshiro Tsukiyama

  6. Advanced Medical-Engineering Development Center, Kobe University, Kobe, Japan

    Takahiro Yasuda

  7. Department of Cardiovascular Medicine, Wakayama Medical University, Wakayama, Japan

    Takashi Kubo

  8. Division of Cardiology, Osaka Saiseikai Nakatsu Hospital, Osaka, Japan

    Amane Kozuki & Junya Shite

Authors
  1. Hiroyuki Kawamori
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  2. Akihide Konishi
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  3. Toshiro Shinke
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  4. Hirokuni Akahori
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  5. Masaharu Ishihara
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  7. Hiromasa Otake
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  8. Takayoshi Toba
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  9. Shinsuke Nakano
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  10. Kosuke Tanimura
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  11. Yoshiro Tsukiyama
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  13. Yasumasa Kakei
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  14. Takahiro Yasuda
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  15. Takashi Omori
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  16. Takashi Kubo
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  17. Amane Kozuki
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  18. Junya Shite
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  19. Ken-ichi Hirata
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Contributions

All authors contributed to the study conception and design. Material preparation and data collection were performed by Hiroyuki Kawamori, Toshiro Shinke, Hirokuni Akahori, Masaharu Ishihara, Hiroaki Tsujita, and Ken-ichi Hirata. Akihide Konishi and Takashi Omori made a great contribution to the analysis of the results and to the writing of the manuscript, and all authors commented on the previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Akihide Konishi.

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Conflict of interest

Masaharu Ishihara and Ken-ichi Hirata received a research grant from the Terumo Corporation. Toshiro Shinke, Hiromasa Otake, Takashi Kubo, Amane Kozuki, and Junya Shite received lecture fees from the Terumo Corporation. The remaining authors have no conflicts of interest.

Ethics approval

This protocol has been approved by the institutional review boards of Kobe University Hospital (protocol identification number: OFDI-01), Showa University, School of Medicine, and Hyogo College of Medicine.

Informed consent

Written informed consent to participate in this study was obtained from all participants.

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Kawamori, H., Konishi, A., Shinke, T. et al. Efficacy of optical frequency domain imaging in detecting peripheral artery disease: the result of a multi-center, open-label, single-arm study. Heart Vessels 36, 818–826 (2021). https://doi.org/10.1007/s00380-020-01758-y

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