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

NCT ID: NCT05138289

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 258 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-12
• Study Completion Date: 2022-11-08

Brief Summary

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).

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.

Conditions

Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Total Plaque Volume

Compare total plaque volume with IVUS obtained during ICA (invasive coronary angiography)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HeartFlow, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jagat Narula, MD

Role: PRINCIPAL_INVESTIGATOR

HeartFlow Investigative Site

Thomas Stuckey, MD

Role: PRINCIPAL_INVESTIGATOR

HeartFlow Investigative site

Gaku Nakazawa, MD

Role: PRINCIPAL_INVESTIGATOR

HeartFlow investigative site

Locations

HeartFlow Investigative Site

Lincoln, Nebraska, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP- 908-001

Identifier Type: -

Identifier Source: org_study_id