Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05524896
Status:
COMPLETED
Last Update Posted:
2022-09-08
First Post:
2022-08-30
Brief Title:
Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography
Sponsor:
Elucid Bioimaging Inc
Organization:
Elucid Bioimaging Inc
Study Overview
Official Title:
Elucidate Vasodilatory Capacity From Histology-Defined Analysis of Coronary CT Angiography
Status:
COMPLETED
Status Verified Date:
2022-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HD-FFRct
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None