Study ID: ReVEAL iFR
Radiographic imaging validation and evaluation for Angio iFR
This trial is studying the Philips Angio-iFR medical software device, which is intended to provide information regarding a coronary artery lesion . The information gathered during the procedure will be put into a large database using only the lesion and blockage information. In the future, researchers will be able to determine the percentage of blockage of the coronary artery by looking at a picture of the artery and using equations built from the information gathered from this study.
Eligible participants are those who are scheduled to undergo cardiac catheterization for diagnostic and/or treatment purposes. Patients must have at least one major epicardial vessel with a significant lesion. Epicardial coronary vessels lie on the outside of the heart and distribute blood flow to different regions of the heart muscle.
This is a multicenter, prospective, single-arm, open-label study of the Philips Angio-iFR medical software device, which is intended to provide information regarding a coronary artery lesion, and thus provide guidance to physicians on diagnostic decisions similar to that obtained through invasive measures.
The software application uses the geometry of the patient’s vessel (obtained from coronary angiography) together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.
The study seeks to demonstrate:
- diagnostic accuracy of image-derived iFR and FFR results for identifying functionally significant lesions as determined by the corresponding invasive measures
- diagnostic agreement of image-derived iFR and FFR estimates with the corresponding invasive measures
- diagnostic performance of image-derived physiology estimate is superior to visual angiographic assessment for the identification of functionally significant stenoses (as determined by the corresponding invasive physiology measures)
- reproducibility of the image-derived estimate for a given operator and across multiple operators for a given lesion
- Must have at least one lesion in a major epicardial vessel of 40% to 90% angiographic stenosis with a reference vessel size ≥2.5mm in the diseased segment
- Must not have acute coronary syndrome within four weeks prior to the scheduled index procedure
- Must not have cardiogenic shock, systolic blood pressure of <90 mmHg or cardiac arrhythmias