Coronary Artery Disease Clinical Trial
Official title:
Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
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.
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 sensitivity and specificity 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. ;
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