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Method for Rapid Non-Invasive Assessment of Coronary Stenosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43HL162240-01
Agency Tracking Number: R43HL162240
Amount: $229,693.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NHLBI
Solicitation Number: PA20-260
Solicitation Year: 2020
Award Year: 2022
Award Start Date (Proposal Award Date): 2022-02-10
Award End Date (Contract End Date): 2023-08-09
Small Business Information
Louisville, KY 40206-2632
United States
DUNS: 117603648
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (615) 554-7000
Business Contact
Phone: (502) 551-7878
Research Institution

vCardio, Inc
Method for Rapid Non-Invasive Assessment of Coronary Stenosis
Project Summary
We have developed a non-invasive technique for quantifying the severity of stenosis (blockage)
in coronary arteries. One million invasive coronary angiography (ICA) procedures are performed
every 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 that
limits blood flow to the heart muscle in the coronary arteries. Almost half of ICAs culminate in
stent placement in coronary arteries in order to relieve the blockage of blood flow. The cardiologist
performing the procedure in the catheterization lab determines the significance of the stenosis by
one 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-invasive
method to assess the significance of coronary stenosis through coronary angiography without
pressure-wire FFR measurement. When performed in real-time, under 2 minutes, this allows the
cardiologist to make an informed decision regarding stent placement. Such a method would
deliver the benefits of pressure-wire FFR measurement in terms of cost savings and improvement
in patient symptoms, while avoiding disadvantages such as extra cost for the procedure and time
burden. It performs favorably compared to competing technology in terms of accuracy but is
superior to competition with regards to the time required to run the software. This allows us to
provide a truly real-time solution for quantification of coronary stenosis.
Our approach uses reduced order modeling methods to model coronary blood flow across
stenotic coronary lesions and assess the degree of stenosis severity by incorporating residence
time of blood flow through the stenotic segments. The major advantage of this approach over the
competing solutions is its potential to deliver a real-time virtual solution within seconds. Once
implemented, the solution would merge seamlessly with the current catheterization lab equipment
and provide a real-time, objective tool for assessment of coronary lesions by the treating
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 a
retrospective study in patients with known CAD who have undergone coronary angiography and
pressure-wire FFR measurement for clinical indications.

* Information listed above is at the time of submission. *

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