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

Angiography-derived physiological assessment of coronary lesions has emerged as an alternative to wire-based aiming at less-invasiveness and shorter procedural time well cost effectiveness in physiology-guided decision making. However, current available image-derived physiology software have limitations including the requirement multiple projections are consuming. The ReVEAL iFR (Radiographic imaging Validation EvALuation for Angio-iFR) trial is a multicenter, multicontinental, validation study which aims validate diagnostic accuracy Angio-iFR medical device (Philips, San Diego, US) patients undergoing angiography Chronic Coronary Syndrome (CCS). will enable operators predict both FFR value within few seconds from single projection cine by using lumped parameter fluid dynamics model. Approximately 440 with least one de-novo 40% 90% stenosis visual angiographic be enrolled study. primary endpoint sensitivity specificity given lesion compared corresponding invasive measures. enrollment started August 2019, was completed March 2021. system potential simplifying evaluation systems, providing estimates iFR. investigate predictive performance novel CCS patients. Ultimately, based on its unique characteristics, may contribute improve adoption functional workflow catheter laboratory.