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This study will evaluate the level of agreement between noninvasive CCTA (coronary computed tomography angiography)-based quantification and characterization of coronary atherosclerosis and invasive IVUS (intravascular ultrasound).
This is a prospective, multi-center study. All patients who have a stenosis in at least one major epicardial vessel confirmed by CCTA, who have undergone FFRCT (Fractional flow reserve-computed tomography) analysis, and who are scheduled to undergo clinically indicated IVUS-guided invasive evaluation and/or treatment will be eligible for enrollment. Enrolling sites will have FFRCT analysis incorporated when indicated into their standard evaluation of CCTA scans. Data collected will include CCTA and FFRCT, full angiographic, and IVUS images, and if obtained, any other imaging or physiologic data including OCT (Optical coherence tomography), FFR (fractional flow reserve), any NHPR (non-hyperemic pressure ratios) (e.g., dPR (diastolic pressure ratio), RFR (resting full-cycle ratio), iFR (instantaneous wave-free ratio), etc.), and pre- and post-stent implantation invasive data. All non-invasive and invasive data collected will be obtained as clinical practice consistent with standard clinical care.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
HeartFlow Investigative Site
Lincoln, Nebraska, United States
Start Date
October 12, 2021
Primary Completion Date
November 8, 2022
Completion Date
November 8, 2022
Last Updated
August 22, 2025
258
ACTUAL participants
Total Plaque Volume
OTHER
Lead Sponsor
HeartFlow, Inc.
NCT06701032
NCT06743672
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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