NCT05524896

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 302 (actual)
• Sponsor: Elucid Bioimaging Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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

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.

Conditions

• Vascular Diseases

Interventions

Type	Name	Description
DEVICE	ElucidVivo	Plaque morphology characterization for predicting non-invasive fractional flow reserve (FFR)

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-05-31
• Completion: 2022-07-13
• First posted: 2022-09-01
• Last updated: 2022-09-08

Regulatory

• FDA-regulated device study