Research correspondence

DOI: 10.4244/EIJ-D-22-01058

Clinical performance of a novel hybrid IVUS-OCT system: a multicentre, randomised, non-inferiority trial (PANOVISION)

Haibo Jia1,2, MD, PhD; Chen Zhao1,2, MD; Huai Yu1,2, MD; Zhao Wang3, PhD; Huimin Liu1,2, MD, PhD; Maoen Xu1,2, MD, PhD; Sining Hu1,2, MD, PhD; Lulu Li1,2, PhD; Luping He1,2, MD; Ziqian Weng1,2, MD; Yuhan Qin1,2, MD; Yishuo Xu1,2, MD; Ming Zeng1,2, MD; Xi Su4, MD, PhD; Bin Liu5, MD, PhD; Jingbo Hou1,2, MD, PhD; Bo Yu1,2, MD, PhD

Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) have been established as important diagnostic and guidance tools for percutaneous coronary intervention (PCI) procedures1. Sequential use of the two modalities might overcome the inherent limitations of each technology; however, the potential risks of complications and cost are hard to ignore. Hybrid IVUS-OCT systems can overcome the limitations associated with each technology and integrate the advantages of both modalities. In 2018, a hybrid IVUS-OCT system for clinical application was reported for the first time2. Recently, a novel hybrid imaging system was approved for clinical use (PANOVISON; Panovision Co., Ltd), allowing synchronous acquisition of the two imaging modalities and an immediate, coregistered image review. We conducted this first-in-human study to test each modality of the hybrid imaging system, representing this novel device’s first large-scale human application.

The study was a prospective, multicentre, randomised, open-label, self-controlled, non-inferiority trial. The protocol was approved by the institutional review boards and ethics committees in all participating centres. All patients provided written informed consent. Specific inclusion and exclusion criteria are described at ClinicalTrials.gov: NCT05596279. We used a web-based randomisation service...

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Volume 19 Number 4
Jul 17, 2023
Volume 19 Number 4
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