NCT06018194

ELUCIDATE FFRct Study

The ELUCIDATE FFRct Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 350 (estimated)
• Sponsor: Elucid Bioimaging Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the diagnostic accuracy of a novel plaque-based coronary CT angiography (CCTA) fractional flow reserve (FFRct) software device for the estimation of invasive fractional flow reserve (FFR). Researchers will compare the Elucid plaque-based FFRct analysis to invasively measured FFR in patients who have previously undergone CCTA and invasively assessed FFR.

Detailed description

Invasive fractional flow reserve is a clinically validated measure of lesion-specific ischemia and is preferred over visual estimation of diameter stenosis for clinical decision-making regarding coronary revascularization in patients with stable clinical presentations. Fractional flow reserve derived from coronary computed tomography angiography (FFRct) using computational fluid dynamic (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 CCTA. However, CFD-based FFRct is calculated based predominately on detailed coronary lumen geometry. It is understood that the burden and type of coronary atherosclerosis, in addition to lumen geometry, significantly impacts the vasodilatory capacity of the coronary endothelium. Preliminary studies suggest that invasive FFR can be accurately estimated based on the quantification of coronary plaque burden and the assessment of plaque composition. Previously, the investigators have demonstrated that a novel plaque-based FFRct approach, using a histologically validated software (ElucidVivoTM) for the measurement of plaque morphology (volume, plaque risk characteristics, and stenosis) to train a deep-learning model, was shown to be accurate and superior to lumen stenosis for predicting invasive FFR in a single-site feasibility study. In this study, the investigators seek to assess the diagnostic accuracy of the Elucid plaque-based FFRct software to estimate invasive FFR in patients at multiple centers.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	ElucidVivo	Plaque morphology characterization on coronary CTA for predicting fractional flow reserve (FFRct)

Timeline

• Start date: 2023-09-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2023-08-30
• Last updated: 2024-02-20

Locations

9 sites across 1 country: United States

Regulatory

• FDA-regulated device study