@article{5e061edc7e014f31863c05d8ff3a9a05,
title = "A prospective multicenter validation study for a novel angiography-derived physiological assessment software: Rationale and design of the radiographic imaging validation and evaluation for Angio-iFR (ReVEAL iFR) study",
abstract = "Angiography-derived physiological assessment of coronary lesions has emerged as an alternative to wire-based assessment aiming at less-invasiveness and shorter procedural time as well as cost effectiveness in physiology-guided decision making. However, current available image-derived physiology software have limitations including the requirement of multiple projections and are time consuming. Methods/Design: The ReVEAL iFR (Radiographic imaging Validation and EvALuation for Angio-iFR) trial is a multicenter, multicontinental, validation study which aims to validate the diagnostic accuracy of the Angio-iFR medical software device (Philips, San Diego, US) in patients undergoing angiography for Chronic Coronary Syndrome (CCS). The Angio-iFR will enable operators to predict both the iFR and FFR value within a few seconds from a single projection of cine angiography by using a lumped parameter fluid dynamics model. Approximately 440 patients with at least one de-novo 40% to 90% stenosis by visual angiographic assessment will be enrolled in the study. The primary endpoint is the sensitivity and specificity of the iFR and FFR for a given lesion compared to the corresponding invasive measures. The enrollment started in August 2019, and was completed in March 2021. The Angio-iFR system has the potential of simplifying physiological evaluation of coronary stenosis compared with available systems, providing estimates of both FFR and iFR. The ReVEAL iFR study will investigate the predictive performance of the novel Angio-iFR software in CCS patients. Ultimately, based on its unique characteristics, the Angio-iFR system may contribute to improve adoption of functional coronary assessment and the workflow in the catheter laboratory.",
keywords = "Angio-iFR, Coronary artery disease, FFR, QFR, ReVEAL iFR, Study design, iFR",
author = "Masafumi Ono and Serruys, {Patrick W.} and Patel, {Manesh R.} and Javier Escaned and Takashi Akasaka and Lavieren, {Martijn A. van} and Christian Haase and Michael Grass and Norihiro Kogame and Hironori Hara and Hideyuki Kawashima and Wykrzykowska, {Joanna J.} and Piek, {Jan J.} and Scot Garg and Neil O'Leary and Becky Inderbitzen and Yoshinobu Onuma",
note = "Funding Information: Dr. Serruys reports personal fees from Sinomedical Sciences Technology, SMT, Philips/Volcano, Novartis, Merillife, and Xeltis, outside the submitted work. Dr. Patel reports grants from Phillips, during the conduct of the study; grants and personal fees from Bayer, grants from AstraZeneca, grants and personal fees from Janssen, grants from NHLBI, grants and personal fees from Heartflow, outside the submitted work. Dr. Escaned reports being a consultant for Abbott, Philips/Volcano, and Boston Scientific; outside the submitted work. Dr. Akasaka reports grants and personal fees as honorarium for lectures from Abbott Vascular Japan, grants from Nipro Corporation, grants from Terumo Corporation, outside the submitted work. Dr. van Lavieren reports personal fees from Royal Philips, during the conduct of the study; personal fees from Royal Philips, outside the submitted work; In addition, Dr. van Lavieren has a patent US20200289078A1 pending, a patent US20190076196A1 pending, a patent US20190076105A1 pending, a patent EP3624132A1 pending, and a patent EP3644274A1 pending. Dr. Haase reports personal fees from Royal Philips, during the conduct of the study; personal fees from Royal Philips, outside the submitted work. Dr. Grass reports personal fees from Royal Philips, during the conduct of the study; personal fees from Royal Philips, outside the submitted work. Dr. Piek reports personal fees and non-financial support from Philips/Volcano, outside the submitted work. Dr. Inderbitzen reports personal fees from Royal Philips, during the conduct of the study; personal fees from Royal Philips, outside the submitted work. Publisher Copyright: {\textcopyright} 2021",
year = "2021",
month = sep,
day = "1",
doi = "https://doi.org/10.1016/j.ahj.2021.05.004",
language = "English",
volume = "239",
pages = "19--26",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Mosby Inc.",
}