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

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A Correction to this article was published on 29 June 2020

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Abstract

Intravascular optical coherence tomography is a high-resolution intracoronary imaging modality, providing a microscopic image of intravascular features. However, it has lower penetration depth than intravascular ultrasound. Recently, a second-generation optical frequency-domain imaging (OFDI) technique has been developed to provide greater penetration depth and faster pullback speed. However, there is little evidence supporting the efficacy of OFDI in patients with peripheral artery disease (PAD) undergoing endovascular treatment (EVT). We aimed to evaluate the ability of OFDI to visualize vessel walls from the superficial femoral artery (SFA) to the below-knee (BK) arteries, as well as the coronary arteries. This clinical trial is a single-center, single-arm, open-label study to be conducted in Japan. A total of 20 patients will be enrolled in this study. The primary endpoint is to obtain a clear image of the intravascular features of the SFA and BK arteries, specifically the visualization of ≥ 270° of the vessel lumen in ≥ 16 out of 21 cross sections. Obtaining clear images in ≥ 85% of cases will be regarded as confirmation of the ability of OFDI to visualize vessel walls from the SFA to the BK arteries. This is the first clinical trial to be conducted accordance with good clinical practice to expand the indications of OFDI for PAD patients undergoing EVT in Japan. The result of this study will help provide another imaging option during EVT in daily practice.

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Change history

  • 29 June 2020

    In the original publication of the article, the author group was published without full names and one of the co-authors’ name was published incorrectly. The full names of author group and correct co-authors’ name are given in this Correction.

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Acknowledgements

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

Funding

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

Author information

Author notes

  1. H. Kawamori and A. Konishi authors contributed equally to this work.

Authors and Affiliations

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

    H. Kawamori, H. Otake, T. Toba, S. Nakano, K. Tanimura & K. Hirata

  2. Kobe University Hospital Clinical and Translational Research Center, Kobe, Japan

    A. Konishi & I. Namba

  3. Hyogo Prefectural Himeji Cardiovascular Center, Himeji, Japan

    Y. Tsukiyama

  4. Division of Biostatistics, Department of Social/Community Medicine and Health Science, Kobe University Graduate School of Medicine, Kobe, Japan

    T. Omori

  5. Division of Cardiovascular Medicine, Showa University School of Medicine, Tokyo, Japan

    T. Shinke

  6. Department of Cardiology, Kobe University Graduate School of Medicine, 7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, 650-0017, Japan

    H. Kawamori

Authors
  1. H. Kawamori
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  2. A. Konishi
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  3. H. Otake
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  8. I. Namba
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  9. T. Omori
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  10. T. Shinke
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  11. K. Hirata
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Corresponding author

Correspondence to H. Kawamori.

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Conflicts of interest

Dr. Otake and Dr. Shinke serve as members of the advisory board of Abbott Vascular, Inc. The remaining authors have no conflicts of interest to declare.

Research involving human participants and/or animals

This protocol has been approved by the institutional review board of Kobe University Hospital (Protocol identification number: OFDI-01).

Informed consent

All patients must provide written informed consent. The principle investigator or sub-investigator will provide potential subjects with opportunities to ask questions and ample time to decide whether or not to provide consent, and should confirm sufficient understanding of the potential subjects about the contents of this study, before obtaining voluntary consent to participate.

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Kawamori, H., Konishi, A., Otake, H. et al. Efficacy of optical frequency-domain imaging in detecting peripheral artery disease: a single-center open-label, single-arm study protocol. Cardiovasc Interv and Ther 35, 385–391 (2020). https://doi.org/10.1007/s12928-019-00636-3

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  • DOI: https://doi.org/10.1007/s12928-019-00636-3

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