Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease

Study Overview
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Brief Summary
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This is a prospective, observational, single-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 in Multi-Vessel Disease.

Official Title
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Angiogram Based Fractional Flow Reserve in Patients With Multi-Vessel Disease

Conditions
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Multi Vessel 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: >18 years of age. Patients with stable angina or unstable angina or NSTEMI, with at least 1 stenoses ≥ 50% in two main vessels (LAD, LCX and/or RCA) each and in whom invasive FFR is being assessed at these stenoses. Patients undergoing invasive FFR with Adenosine, ATP or Papaverine used as hyperemic stimulus. Written, informed consent. Exclusion Criteria: Contraindication for FFR examination or administration of vasodilators. Clinical presentation of an acute infarct (STEMI) or presented with STEMI in past year. CTO in a target vessel. Prior CABG, valvular surgery, TAVI/TAVR, or heart transplantation. 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 lesions involve Left Main (stenosis ≥50%.) In-stent restenosis in a target vessel. Heavily diffused atherosclerosis diseases defined as the presence of diffuse, serial gross luminal irregularities present in the majority of the coronary tree. Target coronary vessels are supplied by major collaterals. Lesion is in ectatic segment which includes dilatation in diameter at least 1.5 times that of the adjacent normal coronary artery. Coronary angiograms not acquired per instructions as defined in the Study Protocol.

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 |