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

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).

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
• Intervention / Treatment: Other: Total Plaque Volume

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 258

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • HeartFlow Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion criteria (all must be present):

1. Age ≥18 years
2. Clinically stable patient with known CAD
3. 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
4. FFRct successfully processed
5. Willing to comply with all aspects of the protocol
6. Agrees to be included in the study and able to provide written informed consent.

Exclusion criteria (all must be absent):

1. 1. CCTA showing no stenosis
2. Uninterpretable CCTA by HeartFlow assessment, in which image quality prevents FFRCT from being processed.
3. Acute chest pain
4. CABG (coronary artery bypass graft) prior to CCTA acquisition
5. Prior history of PCI for 3 or more vessels
6. MI (myocardial infarction) less than 30 days prior to CCTA or between CCTA and ICA.
7. Suspicion of acute coronary syndrome (acute myocardial infarction or unstable angina)
8. Known complex congenital heart disease
9. Tachycardia or significant arrhythmia
10. Subject requires an emergent procedure
11. 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
12. Any active, serious, life-threatening disease with a life expectancy of less than 2 months
13. Currently enrolled in another study utilizing FFRCT or in an investigational trial that involves a non-approved cardiac drug or device
14. Persons under the protection of justice, guardianship, or curatorship

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Total Plaque Volume	Level of agreement between total plaque volume measured by AI-QCPA (Artificial intelligence quantitative coronary plaque analysis) and IVUS (intravascular ultrasound).	13 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
calcified plaque volume, plow attenuated plaque volume, fibrous plaque volume,	Compare with IVUS obtained during ICA	During IVUS procedure
percent plaque burden,	Compare with IVUS obtained during ICA	During IVUS procedure
minimum lumen area	Compare with IVUS obtained during ICA	During IVUS procedure
positive remodeling index and percent area stenosis	Compare with IVUS obtained during ICA	During IVUS procedure

Collaborators and Investigators

• Sponsor: HeartFlow, Inc.
• Investigators: Principal Investigator: Jagat Narula, MD, HeartFlow Investigative Site; Principal Investigator: Thomas Stuckey, MD, HeartFlow Investigative Site; Principal Investigator: Gaku Nakazawa, MD, HeartFlow Investigative Site

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2021
• Primary Completion (Actual): November 8, 2022
• Study Completion (Actual): November 8, 2022

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (Actual): November 30, 2021

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 21, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Ischemia; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Infarction
• Other Study ID Numbers: CP- 908-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No