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ELUCIDATE FFRct Study

CompletedN/A

Sponsor: Elucid Bioimaging Inc.

Conditions: Coronary Artery Disease

Interventions: ElucidVivo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria

1\. Adults \>18 years with CCTA (\>64-detector row) performed within 60 days of undergoing invasive FFR. Exclusion Criteria

1. 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.
2. History of myocardial infarction prior to CCTA and invasive FFR.
3. Known complex congenital heart disease.
4. Existing pacemaker or internal defibrillator lead implantation(s).
5. Existing prosthetic heart valve.
6. Absence of CCTA Digital Imaging and Communications in Medicine (DICOM) data for analysis.
7. Absence of invasive coronary angiography imaging or adequate description defining the position of the invasive FFR wire location.
8. Poor CCTA image quality that does not meet Elucid image processing requirements for plaque and FFRct (See Image Analysis Manual below).
9. Absence of study date for CCTA or invasive FFR.
10. Interval clinical myocardial infarction, diagnosis of decompensated heart failure, stroke, or coronary revascularization procedure between CCTA and invasive FFR.
11. Non-diagnostic CCTA or invasive FFR. Studies where the results of the study were deemed non-diagnostic for clinical decision-making were excluded.
12. CCTA or invasive FFR studies performed prior to 1 January 2012.
13. Subjects who had IFR or CFR and not measured FFR.

Locations (8)

Beverly Hills, California, United States
Atlanta, Georgia, United States
Fort Wayne, Indiana, United States
Overland Park, Kansas, United States
Ridgewood, New Jersey, United States
New York, New York, United States
Nashville, Tennessee, United States
Charlottesville, Virginia, United States