Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
NCT ID: NCT03857503
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
441 participants
OBSERVATIONAL
2019-08-01
2021-03-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Volcano Corporation
INDUSTRY
Responsible Party
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Locations
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VA Medical Center
Long Beach, California, United States
Colorado Heart and Vascular/St Anthony's
Lakewood, Colorado, United States
Yale University Hospital
New Haven, Connecticut, United States
Memorial Regional Hospital
Hollywood, Florida, United States
Memorial Hospital- West
Pembroke Pines, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Ascension St. John Hospital
Detroit, Michigan, United States
Catholic Medical Center
Manchester, New Hampshire, United States
South Side Hospital
Bay Shore, New York, United States
University at Buffalo
Buffalo, New York, United States
St Francis Hospital
Roslyn, New York, United States
Duke University Hospital
Durham, North Carolina, United States
NC Heart & Vascular
Goldsboro, North Carolina, United States
Integris Heart Hospital
Oklahoma City, Oklahoma, United States
Bryn Mawr Hospital
Wynnewood, Pennsylvania, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
Centennial Heart
Nashville, Tennessee, United States
Baylor Scott & White Research Institute
Dallas, Texas, United States
Unversitatklinikum, Freiburg
Freiburg im Breisgau, , Germany
Gemeinschaftsklinikum, Koblenz
Koblenz, , Germany
Universitatklinikum, Mannheim
Mannheim, , Germany
Robert-Bosch Krankenhaus, Stuttgart
Stuttgart, , Germany
University Hospital Galway, CRFG
Galway, , Ireland
Gifu Heart Center
Gifu, , Japan
Ehime Medical University
Matsuyama, , Japan
Wakayama Medical University
Wakayama, , Japan
AMC Amsterdam
Amsterdam, , Netherlands
Amphia Ziekenhuis Breda
Breda, , Netherlands
Medische Spectrum Twente
Enschede, , Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, , Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Hospital Universitario de Léon
León, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Basildon Univeristy Hospital
Basildon, , United Kingdom
Blackpool Victoria hospital
Blackpool, , United Kingdom
Royal Bournemouth hospital
Bournemouth, , United Kingdom
Imperial College of London- Hammersmith Hospital
London, , United Kingdom
University of Southampton
Southampton, , United Kingdom
Countries
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References
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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.
Revaiah 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.
Ono 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.
Other Identifiers
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180102
Identifier Type: -
Identifier Source: org_study_id
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