SBIR-STTR Award

vCardio, Inc Method for Rapid Non-Invasive Assessment of Coronary StenosisWe have developed a non-invasive technique for quantifying the severity of stenosis (blockage) in coronary arteries. One million invasive coronary angiography (ICA) procedures are performe devery year in patients who present with chest pain or are known to have stable coronary artery disease (CAD). The goal of the procedure is to determine if there is any significant stenosis thatlimits blood flow to the heart muscle in the coronary arteries. Almost half of ICAs culminate instent placement in coronary arteries in order to relieve the blockage of blood flow. The cardiologistperforming the procedure in the catheterization lab determines the significance of the stenosis byone of two methods: either by visually estimating the degree of stenosis ("˜eyeballing' the stenosis), which is the routine practice and is done in the majority of patients, or by invasively measuring fractional flow reserve (pressure-wire FFR), which is the Gold Standard test. However, pressure-wire FFR is only performed in 10-20% of patients because it is invasive, expensive, and time-consuming, and requires more radiation and contrast exposure.The proposed technology provides an accurate, highly sensitive and specific, non-invasivemethod to assess the significance of coronary stenosis through coronary angiography withoutpressure-wire FFR measurement. When performed in real-time, under 2 minutes, this allows thecardiologist to make an informed decision regarding stent placement. Such a method woulddeliver the benefits of pressure-wire FFR measurement in terms of cost savings and improvementin patient symptoms, while avoiding disadvantages such as extra cost for the procedure and timeburden. It performs favorably compared to competing technology in terms of accuracy but issuperior to competition with regards to the time required to run the software. This allows us toprovide a truly real-time solution for quantification of coronary stenosis.Our approach uses reduced order modeling methods to model coronary blood flow acrossstenotic coronary lesions and assess the degree of stenosis severity by incorporating residencetime of blood flow through the stenotic segments. The major advantage of this approach over thecompeting solutions is its potential to deliver a real-time virtual solution within seconds. Onceimplemented, the solution would merge seamlessly with the current catheterization lab equipmentand provide a real-time, objective tool for assessment of coronary lesions by the treatingcardiologists.The objective is to scale the study from an initial successful 54 patient study up to 500 patients(400 patients in derivation cohort and 100 patients in validation cohort) by conducting aretrospective study in patients with known CAD who have undergone coronary angiography andpressure-wire FFR measurement for clinical indications.

Public Health Relevance Statement:
vCardio, inc Method for Rapid Non-Invasive Assessment of Coronary Stenosis Project Narrative The proposed technology is a software application that provides an accurate, non- invasive method to assess the significance of blocked coronary arteries and is meant to replace the current invasive medical procedure. This application allows the treating cardiologist to make an informed decision regarding stent placement for patients who have blocked coronary arteries and present with chest pain that is not adequately responsive to medications. Such a non-invasive method would deliver the benefits of the invasive procedure in terms of improvement in patient symptoms, while avoiding disadvantages such as increased radiation exposure and higher contrast use for patients and higher cost for the procedure. The software application is cheaper, easier, and faster than existing invasive procedures. It is also can be faster, easier or more accurate than existing non-invasive procedures. April, 2021

Project Terms:
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