Last updated on December 2019

Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

Brief description of study

The Philips Angio-iFR medical software device is intended to provide information on the functional significance of a coronary artery lesion to provide guidance on diagnostic decisions similar to that obtained through invasive measures of iFR and FFR. The software application uses the vessel geometry obtained from a coronary angiographic image together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.

Detailed Study Description

This study is intended to demonstrate the diagnostic performance of the image-derived physiology model using the invasive physiological measures as the reference standard.

Specific objectives include the following:

i) Demonstrate the diagnostic accuracy of image-derived iFR and FFR results for identifying functionally significant lesions as determined by the corresponding invasive measures; ii) Demonstrate the diagnostic agreement of image-derived iFR and FFR estimates with the corresponding invasive measures; iii) Demonstrate the diagnostic performance of image derived physiology estimate (iFR/FFR) is superior to visual angiographic assessment for the identification of functionally significant stenoses as determined by the corresponding invasive physiology measures; iv) Demonstrate reproducibility of the image-derived estimate for a given operator and across multiple operators for a given lesion.

Clinical Study Identifier: NCT03857503

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