Clinical Trial of the Week: Device trial for patients diagnosed with coronary artery lesion

By Donna Loyle, communications specialist, LIMR

Researchers seek patients who are scheduled to undergo cardiac catheterization for diagnostic and/or treatment purposes for a single-arm, open-label clinical study of the Philips Angio-iFR medical software device. The software 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.

ReVEAL iFR is a multicenter clinical study that is gathering data into a large database using lesion and blockage information obtained from the software. The study’s sponsors hope the software can provide future guidance to physicians on diagnostic decisions similar to that obtained through invasive measures.

Eligible participants 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. They must not have acute coronary syndrome within four weeks prior to the scheduled index procedure. And they must not have cardiogenic shock, systolic blood pressure of <90 mmHg or cardiac arrhythmia.

The trial is approved for Bryn Mawr Hospital and Lankenau Medical Center. The principal investigator is Antonis Pratsos, MD. For more on the ReVEAL iFR clinical trial, visit www.mainlinehealth.org/research/clinical-trials/reveal-ifr.

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