Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR) (ReVEAL)

March 31, 2021 updated by: Volcano Corporation
The Philips Angio-iFR medical software device is intended to provide information on the functional significance of a coronary artery lesion to provide guidance on diagnostic decisions similar to that obtained through invasive measures of iFR and FFR. The software application uses the vessel geometry obtained from a coronary angiographic image together with a lumped parameter physiological model to provide the associated iFR and FFR estimates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is intended to demonstrate the diagnostic performance of the image-derived physiology model using the invasive physiological measures as the reference standard.

Specific objectives include the following:

i) Demonstrate the sensitivity and specificity of image-derived iFR and FFR results for identifying functionally significant lesions as determined by the corresponding invasive measures; ii) Demonstrate the diagnostic agreement of image-derived iFR and FFR estimates with the corresponding invasive measures; iii) Demonstrate the diagnostic performance of image derived physiology estimate (iFR/FFR) is superior to visual angiographic assessment for the identification of functionally significant stenoses as determined by the corresponding invasive physiology measures; iv) Demonstrate reproducibility of the image-derived estimate for a given operator and across multiple operators for a given lesion.

Study Type

Observational

Enrollment (Actual)

441

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Freiburg, Germany
        • Unversitatklinikum, Freiburg
      • Koblenz, Germany
        • Gemeinschaftsklinikum, Koblenz
      • Mannheim, Germany
        • Universitatklinikum, Mannheim
      • Stuttgart, Germany
        • Robert-Bosch Krankenhaus, Stuttgart
  • Ireland
      • Galway, Ireland
        • University Hospital Galway, CRFG
  • Japan
      • Gifu, Japan
        • Gifu Heart Center
      • Matsuyama, Japan
        • Ehime Medical University
      • Wakayama, Japan, 99999
        • Wakayama Medical University
  • Netherlands
      • Amsterdam, Netherlands
        • AMC Amsterdam
      • Breda, Netherlands
        • Amphia Ziekenhuis Breda
      • Enschede, Netherlands
        • Medische Spectrum Twente
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Nieuwegein, Netherlands
        • Sint Antonius Ziekenhuis
      • Nijmegen, Netherlands
        • Radboud UMC
  • Spain
      • León, Spain
        • Hospital Universitario de Leon
      • Madrid, Spain
        • Hospital Clinico San Carlos
  • United Kingdom
      • Basildon, United Kingdom, SS165NL
        • Basildon Univeristy Hospital
      • Blackpool, United Kingdom
        • Blackpool Victoria Hospital
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • London, United Kingdom, W12OHS
        • Imperial College of London- Hammersmith Hospital
      • Southampton, United Kingdom
        • University of Southampton
  • United States
    • California
      • Long Beach, California, United States, 90822
        • VA Medical Center
    • Colorado
      • Lakewood, Colorado, United States, 80228
        • Colorado Heart and Vascular/St Anthony's
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University Hospital
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Regional Hospital
      • Pembroke Pines, Florida, United States, 33028
        • Memorial Hospital- West
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Hospital
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Midwest Cardiovascular Research Foundation
    • Michigan
      • Detroit, Michigan, United States, 48236
        • Ascension St. John Hospital
    • New Hampshire
      • Manchester, New Hampshire, United States, 03102
        • Catholic Medical Center
    • New York
      • Bay Shore, New York, United States, 11706
        • South Side Hospital
      • Buffalo, New York, United States, 14203
        • University at Buffalo
      • Roslyn, New York, United States, 11576
        • St Francis Hospital
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Hospital
      • Goldsboro, North Carolina, United States, 27607
        • NC Heart & Vascular
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Heart Hospital
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Lankenau Medical Center
      • Wynnewood, Pennsylvania, United States, 19010
        • Bryn Mawr Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Centennial Heart
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor Scott & White Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients referred for cardiac catheterization for diagnostic and/or treatment purposes will undergo a screening angiogram to assess eligibility. Eligible patients will be those with at least one major epicardial vessel having a lesion of 40-90% diameter stenosis per visual assessment of angiogram.

Description

Inclusion Criteria:

  1. ≥18 years old
  2. At least 1 de-novo lesion in 1 or more major epicardial vessels of 40-90% angiographic stenosis with a reference vessel size ≥2.5mm in the diseased segment by visual estimate
  3. Able and willing to provide informed consent

Exclusion Criteria:

  1. Presenting with an acute coronary syndrome (ACS), or documented ACS within 4 weeks prior to the scheduled index procedure
  2. Cardiogenic shock (sustained (>10 min) systolic blood pressure <90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump)
  3. Presence of cardiac arrhythmias (e.g., atrial fibrillation, AV-block)
  4. Prior cardiac surgery or implant, including CABG, heart transplant, surgical heart valve replacement or repair, TAVI/TAVR, presence of an ICD or pacemaker
  5. Target vessel supplied by a left main coronary artery demonstrating any disease present (isolated or non-isolated)
  6. Target vessel supplied by right coronary artery demonstrating any ostial disease (located immediately at the origin of the coronary vessels from the aorta)
  7. Target vessel with Chronic Total Occlusion (CTO) in the ipsilateral territory or target vessel with an untreated CTO in the contralateral territory. Note: if a CTO existing in the contralateral territory is successfully opened, the target vessel in the contralateral territory can be included following CTO treatment.
  8. Target vessel with severe tortuosity (≥1 bends of 90° or more, or ≥3 or more bends of 45°- 90° proximal to the diseased segment)
  9. Target vessel with heavy calcification (multiple persisting opacifications of the coronary wall visible in more than one projection surrounding the complete lumen of the coronary artery at the site of the lesion.)
  10. Target vessel with TIMI flow grade 1 or 0
  11. Target vessel with severe diffuse disease (more than 75% of the length of the segment having a vessel diameter of 2mm, irrespective of the presence or absence of a lesion)
  12. Target lesion is at a bifurcation/trifurcation
  13. Target arteries supplying akinetic or severely hypokinetic territories if already known based on prior imaging
  14. Target vessel is supplied by major collaterals
  15. Target stenosis associated with myocardial bridge
  16. Any vascular abnormality precluding optimal contrast opacification (e,g, thrombus, ulceration)
  17. Severe aortic or mitral valve disease
  18. Known ejection fraction ≤30%
  19. Known severe renal insufficiency (eGFR<30ml/min/1.72m2)
  20. Any fluoroscopic interference that renders the wire position unclear
  21. Contraindication for adenosine or other hyperemic agent (e.g., caffeine ingestion ≤18 hours, COPD, hypotension, AV block)
  22. Known pregnancy or planning to become pregnant
  23. Participating in another interventional investigational study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coronary Lesion Assessment with iFR
Patients referred for cardiac catheterization for diagnostic and/or treatment purposes will undergo a screening angiogram to assess eligibility. Eligible patients will be those with at least one major epicardial vessel having a lesion of 40-90% diameter stenosis per visual assessment of angiogram.
Diagnostic test: iFR

Patients will undergo standard of care diagnostic coronary angiography using established invasive physiological criteria for iFR and FFR to aid in clinical decision making for coronary revascularization.

Angiograms will be made in at least two projections, and the treating physician will record his/her estimation of stenosis severity.

Resting iFR and Pd/Pa measures will then be made distal to the target lesion; adenosine will be administered, and the FFR measures will be made without moving the wire. An iFR pullback will then be made after hyperemia as abated. Patients will be treated or deferred from treatment based on physician decision aided by the iFR measures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy of the image-derived iFR
Time Frame: 1 day
Diagnostic accuracy of the image-derived iFR and FFR estimate for a given lesion compared to the corresponding invasive iFR and FFR values.
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Volcano Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2019

Primary Completion (Actual)

March 12, 2021

Study Completion (Actual)

March 12, 2021

Study Registration Dates

First Submitted

November 12, 2018

First Submitted That Met QC Criteria

February 25, 2019

First Posted (Actual)

February 28, 2019

Study Record Updates

Last Update Posted (Actual)

April 1, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 180102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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