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

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ClinicalTrials.gov Identifier: NCT05138289
Recruitment Status : Completed
First Posted : November 30, 2021
Last Update Posted : December 15, 2022
Sponsor:
Information provided by (Responsible Party):
HeartFlow, Inc.

Tracking Information
First Submitted Date September 24, 2021
First Posted Date November 30, 2021
Last Update Posted Date December 15, 2022
Actual Study Start Date October 12, 2021
Actual Primary Completion Date November 8, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 17, 2021)		 total plaque volume [ Time Frame: During IVUS procedure ]
Compare total plaque volume with IVUS obtained during ICA
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: November 17, 2021)
  • calcified plaque volume, plow attenuated plaque volume, fibrous plaque volume, [ Time Frame: During IVUS procedure ]
    Compare with IVUS obtained during ICA
  • percent plaque burden, [ Time Frame: During IVUS procedure ]
    Compare with IVUS obtained during ICA
  • minimum lumen area [ Time Frame: During IVUS procedure ]
    Compare with IVUS obtained during ICA
  • positive remodeling index and percent area stenosis [ Time Frame: During IVUS procedure ]
    Compare with IVUS obtained during ICA
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA
Official Title The REVEALPLAQUE Study: A pRospEctiVe, multicEnter Study to AnaLyze PLAQUE Using CCTA
Brief Summary This study will evaluate the level of agreement between noninvasive CCTA-based quantification and characterization of coronary atherosclerosis and invasive IVUS .
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 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration 1 Day
Biospecimen Not Provided
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.
Condition Coronary Artery Disease
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 13, 2022)		 258
Original Estimated Enrollment
 (submitted: November 17, 2021)		 250
Actual Study Completion Date November 8, 2022
Actual Primary Completion Date November 8, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT05138289
Other Study ID Numbers CP- 908-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Current Responsible Party HeartFlow, Inc.
Original Responsible Party Same as current
Current Study Sponsor HeartFlow, Inc.
Original Study Sponsor Same as current
Collaborators Not Provided
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
PRS Account HeartFlow, Inc.
Verification Date December 2022