Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography

Study Overview
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Brief Summary
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Coronary CT Angiography (CCTA) may be an ideal modality to fill gaps in understanding the extent and rate of progression coronary artery disease. The investigators have developed an image analysis software ElucidVivo that estimates relevant indices, including fractional flow reserve (FFR) . In this study, the investigators aim to assess the value of ElucidVivo-based plaque morphology characterization for predicting non-invasive FFR in patients with suspected coronary artery disease (CAD) who had undergone clinically indicated coronary CTA and invasive coronary angiography (ICA) for physical FFR measurement.

Detailed Description
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Invasive FFR is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decisions regarding coronary revascularization. FFR derived from coronary CTA (FFRct) using computational fluid dynamics (CFD)-based software has been shown to be a reasonably accurate estimate of invasive FFR and is included in contemporary guidelines as a decision-tool for management of patients with intermediate stenosis on coronary CTA. However, other methods have limitations. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen stenosis, significantly impacts the vasodilatory capacity of the vessel walls which may provide a more interpretable analysis and broader clinical acceptance.

Official Title
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Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography

Conditions
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Vascular Diseases

Intervention / Treatment
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* Device: ElucidVivo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have successfully completed at least one (possibly multiple) CCTA for known or suspected coronary artery disease. CCTA was no more than 60 days earlier (and not later) Exclusion Criteria: Subject has a history of percutaneous coronary intervention (PCI) with stent implantation and/or coronary artery bypass grafting (CABG) Subject with insufficient CCTA image quality (defined strictly as documented in the ElucidVivo Reading Manual)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low FFR<br>Invasive FFR value <= 0.8 | Device: ElucidVivo<br>* Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)<br>|
| High FFR<br>Invasive FFR value > 0.8 | Device: ElucidVivo<br>* Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | the ability of a test to correctly identify patients with low FFR | 1 day | 
| Specificity | the ability of a test to correctly identify people without low FFR | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Error | Difference of noninvasive result - invasive result | 1 day |