NCT06018194Completed
ELUCIDATE FFRct Study
The ELUCIDATE FFRct Study
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 439 (actual)
- First submitted
- 23 Aug 2023
- Start date
- 1 Sept 2023
- Primary completion date
- 28 Jul 2025
- Lead sponsor
- Elucid Bioimaging Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT06018194
What you commit to
- Study type: Observational
- Participants enrolled: 439
- From 1 Sept 2023 to the primary completion date, 28 Jul 2025
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 1\. Adults \>18 years with 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 (See Image Analysis Manual below).
- 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 were excluded.
- CCTA or invasive FFR studies performed prior to 1 January 2012.
- Subjects who had IFR or CFR and not measured FFR.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Piedmont Healthcare Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Cardiovascular Medical Group of Southern California Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Parkview Health Coordinator of this site? Confirm its status | Fort Wayne | United States | Unknown status |
| Ascension Medical Group Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Mount Sinai Morningside Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Midwest Heart and Vascular Specialists Coordinator of this site? Confirm its status | Overland Park | United States | Unknown status |
| Valley Health System Coordinator of this site? Confirm its status | Ridgewood | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.