Radiographic imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
This study enrolls adults with a blockage in an artery in their heart that needs to be tested to determine if it should be treated. The purpose of this study is to collect data and measurements to find out if you need you need an interventional procedure to open your blood vessel or artery.
To find out if you will need a further procedure, your doctor will typically take an x-ray picture with dye to locate blockages in your heart arteries. If pressure measurements are needed, you can be enrolled in the study. The Pressure Wire will be inserted into the artery and placed past the blocked area in
your artery to record some heart measurements. The measurements are called the instantaneous wave-Free Ratio (iFR) and the Fractional Flow Reserve (FFR), and both will be used in this study. Usually people only have one of the two types of measurements taken- we want to find out if taking both is helpful. You will also have a follow up call with our team a few days after your procedure. Study takes place at Buffalo General medical Center and Gates Vascular Institute in Buffalo, NY.
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.
Adults ages 18+.
Have at least 1 non-stented lesion in 1 or more major epicardial vessels of 40-90% angiographic stenosis.
Let us know how the study team can reach you.
If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email email@example.com and someone will assist you.