Status:
RECRUITING
ELUCIDATE FFRct Study
Lead Sponsor:
Elucid Bioimaging Inc.
Collaborating Sponsors:
Lundquist Institute at Harbor-UCLA Medical Center
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief 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 frac...
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 coron...
Eligibility Criteria
Inclusion
- \- Adults \>=18 years with at least one 30-90% stenosis on CCTA (\>64- detector row) performed within 60 days of undergoing invasive FFR.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06018194
Start Date
September 1 2023
End Date
July 31 2024
Last Update
February 20 2024
Active Locations (9)
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1
Cardiovascular Medical Group of Southern California
Beverly Hills, California, United States, 90210
2
Piedmont Healthcare
Atlanta, Georgia, United States, 30309
3
Parkview Health
Fort Wayne, Indiana, United States, 46845
4
Midwest Heart and Vascular Specialists
Overland Park, Kansas, United States, 66211