The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA

Conditions
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Coronary Artery Disease

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total plaque volume | Compare total plaque volume with IVUS obtained during ICA | During IVUS procedure |