Cardiac IschemiaReVEALNCT03857503
Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
An observational study of Cardiac Ischemia and Coronary Artery Disease, run by Volcano Corporation at 40 sites in 7 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Ischemia, Coronary Artery Disease, Coronary Stenosis
- What is being tested?
- iFR
- How many people
- 441 participants
- Where
- 40 sitesin 7 countries
- Study dates
- 1 Aug 2019to 12 Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥18 years old
- 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
- Able and willing to provide informed consent
Who cannot join
- Presenting with an acute coronary syndrome (ACS), or documented ACS within 4 weeks prior to the scheduled index procedure
- Cardiogenic shock (sustained (>10 min) systolic blood pressure <90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump)
- Presence of cardiac arrhythmias (e.g., atrial fibrillation, AV-block)
- Prior cardiac surgery or implant, including CABG, heart transplant, surgical heart valve replacement or repair, TAVI/TAVR, presence of an ICD or pacemaker
- Target vessel supplied by a left main coronary artery demonstrating any disease present (isolated or non-isolated)
- Target vessel supplied by right coronary artery demonstrating any ostial disease (located immediately at the origin of the coronary vessels from the aorta)
Show all 23Show fewer
- 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.
- Target vessel with severe tortuosity (≥1 bends of 90° or more, or ≥3 or more bends of 45°- 90° proximal to the diseased segment)
- 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.)
- Target vessel with TIMI flow grade 1 or 0
- 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)
- Target lesion is at a bifurcation/trifurcation
- Target arteries supplying akinetic or severely hypokinetic territories if already known based on prior imaging
- Target vessel is supplied by major collaterals
- Target stenosis associated with myocardial bridge
- Any vascular abnormality precluding optimal contrast opacification (e,g, thrombus, ulceration)
- Severe aortic or mitral valve disease
- Known ejection fraction ≤30%
- Known severe renal insufficiency (eGFR<30ml/min/1.72m2)
- Any fluoroscopic interference that renders the wire position unclear
- Contraindication for adenosine or other hyperemic agent (e.g., caffeine ingestion ≤18 hours, COPD, hypotension, AV block)
- Known pregnancy or planning to become pregnant
- Participating in another interventional investigational study
Trial locations and contacts
40 sites in 7 countries.
40 sites in 7 countries
United States19 sites
Emory University Hospital
Atlanta, Georgia, 30322
South Side Hospital
Bay Shore, New York, 11706
University at Buffalo
Buffalo, New York, 14203
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
Ascension St. John Hospital
Detroit, Michigan, 48236
Duke University Hospital
Durham, North Carolina, 27710
NC Heart & Vascular
Goldsboro, North Carolina, 27607
Memorial Regional Hospital
Hollywood, Florida, 33021
Colorado Heart and Vascular/St Anthony's
Lakewood, Colorado, 80228
VA Medical Center
Long Beach, California, 90822
Catholic Medical Center
Manchester, New Hampshire, 03102
Centennial Heart
Nashville, Tennessee, 37203
Yale University Hospital
New Haven, Connecticut, 06510
Integris Heart Hospital
Oklahoma City, Oklahoma, 73112
Memorial Hospital- West
Pembroke Pines, Florida, 33028
St Francis Hospital
Roslyn, New York, 11576
Bryn Mawr Hospital
Wynnewood, Pennsylvania, 19010
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Netherlands6 sites
AMC Amsterdam
Amsterdam
Amphia Ziekenhuis Breda
Breda
Medische Spectrum Twente
Enschede
Medisch Centrum Leeuwarden
Leeuwarden
Sint Antonius Ziekenhuis
Nieuwegein
Radboud UMC
Nijmegen
United Kingdom5 sites
Basildon Univeristy Hospital
Basildon, SS165NL
Blackpool Victoria hospital
Blackpool
Royal Bournemouth hospital
Bournemouth, BH7 7DW
Imperial College of London- Hammersmith Hospital
London, W12OHS
University of Southampton
Southampton
Germany4 sites
Unversitatklinikum, Freiburg
Freiburg im Breisgau
Gemeinschaftsklinikum, Koblenz
Koblenz
Universitatklinikum, Mannheim
Mannheim
Robert-Bosch Krankenhaus, Stuttgart
Stuttgart
Japan3 sites
Gifu Heart Center
Gifu
Ehime Medical University
Matsuyama
Wakayama Medical University
Wakayama, 99999
Spain2 sites
Hospital Universitario de Léon
León
Hospital Clinico San Carlos
Madrid
About this study
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.
Read the 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:
- 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.
- Conditions
- Cardiac Ischemia, Coronary Artery Disease, Coronary Stenosis
- Being tested
- iFR
- Medical subject headings
- Coronary Artery Disease, Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iFRDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: iFR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of the image-derived iFR
Diagnostic accuracy of the image-derived iFR and FFR estimate for a given lesion compared to the corresponding invasive iFR and FFR values.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2019
- Study start1 Aug 2019
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Volcano Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857503
- Sponsor's protocol ID
- 180102
- Acronym
- ReVEAL
- Status last verified
- Mar 2021
- First submitted
- 12 Nov 2018
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Onuma Y, Ninomiya K, Sjauw K, Damman P, Matsuo H, von Birgelen C, Sevestre E, Ono M, O'Leary N, Garg S, van Lavieren MA, Inderbitzen B, Akasaka T, Escaned J, Patel MR, Serruys PW; ReVEAL iFR Investigators. Accuracy of instantaneous wave-free ratio and fractional flow reserve derived from single coronary angiographic projections. Am Heart J. 2025 Oct;288:111-121. doi: 10.1016/j.ahj.2025.03.001. Epub 2025 Mar 11.
PubMed 40081745Revaiah PC, Tsai TY, Chinhenzva A, Miyashita K, Tobe A, Oshima A, Ferraz-Costa G, Garg S, Biscaglia S, Patel M, Collet C, Akasaka T, Escaned J, Onuma Y, Serruys PW. Physiological Disease Pattern as Assessed by Pull Back Pressure Gradient Index in Vessels With FFR/iFR Discordance. JACC Cardiovasc Interv. 2025 Apr 14;18(7):823-834. doi: 10.1016/j.jcin.2024.12.017. Epub 2025 Feb 19.
PubMed 39985510Ono M, Serruys PW, Patel MR, Escaned J, Akasaka T, Lavieren MAV, Haase C, Grass M, Kogame N, Hara H, Kawashima H, Wykrzykowska JJ, Piek JJ, Garg S, O'Leary N, Inderbitzen B, Onuma Y. A prospective multicenter validation study for a novel angiography-derived physiological assessment software: Rationale and design of the radiographic imaging validation and evaluation for Angio-iFR (ReVEAL iFR) study. Am Heart J. 2021 Sep;239:19-26. doi: 10.1016/j.ahj.2021.05.004. Epub 2021 May 13.
PubMed 33992606
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
- ClinicalTrials.gov ID
- NCT03857503
- Acronym / sponsor ID
- ReVEAL / 180102
- Conditions
- Cardiac Ischemia, Coronary Artery Disease, Coronary Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Volcano CorporationIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 28 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary Lesion Assessment with iFR | – | Diagnostic Test: iFRPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- ≥18 years old
- 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
- Able and willing to provide informed consent
Key exclusion criteria (23 listed)
- Presenting with an acute coronary syndrome (ACS), or documented ACS within 4 weeks prior to the scheduled index procedure
- Cardiogenic shock (sustained (>10 min) systolic blood pressure <90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump)
- Presence of cardiac arrhythmias (e.g., atrial fibrillation, AV-block)
- Prior cardiac surgery or implant, including CABG, heart transplant, surgical heart valve replacement or repair, TAVI/TAVR, presence of an ICD or pacemaker
- Target vessel supplied by a left main coronary artery demonstrating any disease present (isolated or non-isolated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iFRPatients 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. | Diagnostic test | Coronary Lesion Assessment with iFR |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 40081745Onuma Y, Ninomiya K, Sjauw K, Damman P, Matsuo H, von Birgelen C, Sevestre E, Ono M, O'Leary N, Garg S, van Lavieren MA, Inderbitzen B, Akasaka T, Escaned J, Patel MR, Serruys PW; ReVEAL iFR Investigators. Accuracy of instantaneous wave-free ratio and fractional flow reserve derived from single coronary angiographic projections. Am Heart J. 2025 Oct;288:111-121. doi: 10.1016/j.ahj.2025.03.001. Epub 2025 Mar 11.
- Derived from this study: PubMed 39985510Revaiah PC, Tsai TY, Chinhenzva A, Miyashita K, Tobe A, Oshima A, Ferraz-Costa G, Garg S, Biscaglia S, Patel M, Collet C, Akasaka T, Escaned J, Onuma Y, Serruys PW. Physiological Disease Pattern as Assessed by Pull Back Pressure Gradient Index in Vessels With FFR/iFR Discordance. JACC Cardiovasc Interv. 2025 Apr 14;18(7):823-834. doi: 10.1016/j.jcin.2024.12.017. Epub 2025 Feb 19.
- Derived from this study: PubMed 33992606Ono M, Serruys PW, Patel MR, Escaned J, Akasaka T, Lavieren MAV, Haase C, Grass M, Kogame N, Hara H, Kawashima H, Wykrzykowska JJ, Piek JJ, Garg S, O'Leary N, Inderbitzen B, Onuma Y. A prospective multicenter validation study for a novel angiography-derived physiological assessment software: Rationale and design of the radiographic imaging validation and evaluation for Angio-iFR (ReVEAL iFR) study. Am Heart J. 2021 Sep;239:19-26. doi: 10.1016/j.ahj.2021.05.004. Epub 2021 May 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Ischemia and Coronary Artery Disease, run by Volcano Corporation at 40 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Netherlands, United Kingdom, Germany, Japan and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of the image-derived iFR (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03857503, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.