The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA (REVEALPLAQUE)
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This study will evaluate the level of agreement between noninvasive CCTA-based quantification and characterization of coronary atherosclerosis and invasive IVUS .
Condition or disease
Coronary Artery Disease
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 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, FFR, any NHPR (e.g., dPR, RFR, iFR, 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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Clinically stable patients with known CAD who have a CCTA showing stenosis in at least one major epicardial vessel of stentable/graftable diameter and in whom clinically-indicated IVUS is planned.
Inclusion criteria (all must be present):
Age ≥18 years
Clinically stable patient with known CAD
CCTA showing stenosis in at least one major epicardial vessel of stentable/graftable diameter, in whom clinically indicated IVUS is planned within 45 days of the CCTA and FFRct available
FFRct successfully processed
Willing to comply with all aspects of the protocol
Agrees to be included in the study and able to provide written informed consent.
Exclusion criteria (all must be absent):
1. CCTA showing no stenosis
Uninterpretable CCTA by HeartFlow assessment, in which image quality prevents FFRCT from being processed.
Acute chest pain
CABG prior to CCTA acquisition
Prior history of PCI for 3 or more vessels
MI less than 30 days prior to CCTA or between CCTA and ICA.
Suspicion of acute coronary syndrome (acute myocardial infarction or unstable angina)
Known complex congenital heart disease
Tachycardia or significant arrhythmia
Subject requires an emergent procedure
Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure <90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema
Any active, serious, life-threatening disease with a life expectancy of less than 2 months
Currently enrolled in another study utilizing FFRCT or in an investigational trial that involves a non-approved cardiac drug or device
Persons under the protection of justice, guardianship, or curatorship