Efficacy of optical frequency-domain imaging in detecting peripheral artery disease: a single-center open-label, single-
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ORIGINAL ARTICLE
Efficacy of optical frequency‑domain imaging in detecting peripheral artery disease: a single‑center open‑label, single‑arm study protocol H. Kawamori1,6 · A. Konishi2 · H. Otake1 · T. Toba1 · S. Nakano1 · K. Tanimura1 · Y. Tsukiyama3 · I. Namba2 · T. Omori4 · T. Shinke5 · K. Hirata1 Received: 2 October 2019 / Accepted: 15 December 2019 © Japanese Association of Cardiovascular Intervention and Therapeutics 2020
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 secondgeneration 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. Keywords Optical coherence tomography · Peripheral artery disease · Optical frequency-domain imaging · Endovascular treatment
Introduction
Electronic supplementary material The online version of this article (https://doi.org/10.1007/s12928-019-00636-3) contains supplementary material, which is available to authorized users. H. Kawamori and A. Konishi authors contributed equally to this work. * H. Kawamori [email protected] 1
Division of Cardiovascular Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
2
Kobe University Hospital Clinical and Translational Research Center, Kobe, Japan
3
Hyogo Prefectural Himeji Cardiovascular Center, Himeji, Japan
Endovascular treatment (EVT) is commonly employed in patients with peripheral arterial diseases (PAD). Although angiography has been widely used as imaging guidance for EVT, it provides little information about the vessel wall or the plaque lining it [1–4]. Intravascular ultrasound (IVUS) was introduced to overcome these limitations [5, 6], but only the VH® IVUS (Volcano Corporation, Rancho Cordova, CA) an
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