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

Coronary Artery Disease Clinical Trial

— REVEALPLAQUE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05138289
• Other study ID #: CP- 908-001
• Status: Completed
• Start date: October 12, 2021
• Est. completion date: November 8, 2022

Study information

• Verified date: December 2022
• Source: HeartFlow, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This study will evaluate the level of agreement between noninvasive CCTA-based quantification and characterization of coronary atherosclerosis and invasive IVUS .

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: November 8, 2022
• Est. primary completion date: November 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 prior to CCTA acquisition

5. Prior history of PCI for 3 or more vessels

6. MI 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 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

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
United States	HeartFlow Investigative Site	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
HeartFlow, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	calcified plaque volume, plow attenuated plaque volume, fibrous plaque volume,	Compare with IVUS obtained during ICA	During IVUS procedure
Other	percent plaque burden,	Compare with IVUS obtained during ICA	During IVUS procedure
Other	minimum lumen area	Compare with IVUS obtained during ICA	During IVUS procedure
Other	positive remodeling index and percent area stenosis	Compare with IVUS obtained during ICA	During IVUS procedure
Primary	total plaque volume	Compare total plaque volume with IVUS obtained during ICA	During IVUS procedure