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

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 (coronary artery bypass graft) prior to CCTA acquisition
• Prior history of PCI for 3 or more vessels
• MI (myocardial infarction) 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 [New York Heart Association] 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