ELUCIDATE FFRct Study

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.

Eligibility

Inclusion Criteria:

\- Adults \>=18 years with at least one 30-90% stenosis on CCTA (\>64- detector row) performed within 60 days of undergoing invasive FFR.

Exclusion Criteria:

* History of coronary revascularization with coronary artery bypass graft (CABG) surgery and/or percutaneous coronary intervention (PCI) (stent or balloon angioplasty) prior to CCTA and invasive FFR.
* History of myocardial infarction prior to CCTA and invasive FFR.
* Known complex congenital heart disease.
* Existing pacemaker or internal defibrillator lead implantation(s).
* Existing prosthetic heart valve.
* Absence of CCTA Digital Imaging and Communications in Medicine (DICOM) data for analysis.
* Absence of invasive coronary angiography imaging or adequate description defining the position of the invasive FFR wire location.
* Poor CCTA image quality that does not meet Elucid image processing requirements for plaque and FFRct.
* Absence of study date for CCTA or invasive FFR.
* Interval clinical myocardial infarction, diagnosis of decompensated heart failure, stroke, or coronary revascularization procedure between CCTA and invasive FFR.
* Non-diagnostic CCTA or invasive FFR. Studies where the results of the study were deemed non-diagnostic for clinical decision-making will be excluded.
* CCTA or invasive FFR studies performed prior to 1 January 2016.

Conditions2

Locations9 sites

Browse More Trials