FFRangio Accuracy vs. Standard FFR

Study Overview
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Brief Summary
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This is a prospective, observational, multi-center, single-arm, clinical trial designed to assess the efficacy of FFRangio in measuring FFR obtained from angiography compared to Invasive FFR for diagnosing hemodynamically significant coronary stenosis.

Official Title
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FFRangio Accuracy vs. Standard FFR

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: FFRangio


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, >18 years of age. Patients with stable angina or unstable angina or NSTEMI, and in whom invasive FFR is being assessed in a non-culprit stenosis in at least one coronary artery. Subject is undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus. Provides written, informed consent (where required) Exclusion Criteria: Contraindication for FFR examination or administration of vasodilators. Subject is presenting with acute infarct (STEMI) OR has documented prior STEMI on same side (right/left). CTO in target vessel. Prior CABG, heart transplant or valve surgery, or prior TAVI/TAVR. Known LVEF ≤45%. Arteries supplying akinetic or severe hypokinetic territories if already known based on prior imaging. TIMI Grade 2 or lower at baseline. Target lesion involves Left Main (stenosis >50%). PCI with stent in target vessel in past 12 months, or target vessel involves in-stent restenosis. Severe, diffuse disease defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree. Target coronary vessel is supplied by major collaterals.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FFRangio|FFRangio is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of the coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The CathWorks FFRangio software device is able to perform all required processing and calculations, based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure. The CathWorks FFRangioTM technology does not require any additional use of invasive devices, or any additional vasodilation treatment, as required by other known FFR techniques.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the dichotomously scored FFRangio measured index compared to invasive FFR | Sensitivity and specificity of the dichotomously scored FFRangio measured index per vessel as compared with invasively-derived FFR; Index ≤ 0.80 is scored positive while Index > 0.8 is negative. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continuously scored FFR (FFRangio and Invasive FFR). | Regression of FFRangio on continuous FFR, with slope, intercept and the correlation coefficient. | 1 hour | 
| Accuracy, Positive predictive value and negative predictive value per vessel and per lesion |  | 1 hour | 
| Sensitivity and specificity of the dichotomously scored FFRangio measured index per lesion as measured by the site. |  | 1 hour | 
| Device Success | The ratio of produced FFRangio values from all FFRangio measurements that were started. | 1 hour | 
| Usability of FFRangio | A questionnaire will be completed by the user to assess how easy the system is for use and how intuitive it is. | 1 hour | 
| Comprehensiveness of the FFRangio User Manual in providing adequate instructions | A questionnaire will be completed to measure if the user understands the main parts of the software instructions after reading the Instructions for use. | 1 hour | 
| Procedure related Adverse and Serious Adverse Events |  | 1 hour | 
| Device related Adverse and Serious Adverse Events |  | 1 hour |