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

NCT03857503 | Completed

• 1 other identifier: 180102
• Study Type: observational
• Target: 441
• Locations: 7 countries
• Sites: 40

Brief 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. 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.

Conditions

Cardiac Ischemia; Coronary Artery Disease; Coronary Stenosis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Study Arms (1)

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

Interventions

iFR DIAGNOSTIC_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.

Coronary Lesion Assessment with iFR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Volcano Corporation: lead

Study Sites (40)

VA Medical Center

Long Beach, California, 90822, United States

Location

Colorado Heart and Vascular/St Anthony's

Lakewood, Colorado, 80228, United States

Location

Yale University Hospital

New Haven, Connecticut, 06510, United States

Location

Memorial Regional Hospital

Hollywood, Florida, 33021, United States

Location

Memorial Hospital- West

Pembroke Pines, Florida, 33028, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

South Side Hospital

Bay Shore, New York, 11706, United States

Location

University at Buffalo

Buffalo, New York, 14203, United States

Location

St Francis Hospital

Roslyn, New York, 11576, United States

Location

Duke University Hospital

Durham, North Carolina, 27710, United States

Location

NC Heart & Vascular

Goldsboro, North Carolina, 27607, United States

Location

Integris Heart Hospital

Oklahoma City, Oklahoma, 73112, United States

Location

Bryn Mawr Hospital

Wynnewood, Pennsylvania, 19010, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

Centennial Heart

Nashville, Tennessee, 37203, United States

Location

Baylor Scott & White Research Institute

Dallas, Texas, 75246, United States

Location

Unversitatklinikum, Freiburg

Freiburg im Breisgau, Germany

Location

Gemeinschaftsklinikum, Koblenz

Koblenz, Germany

Location

Universitatklinikum, Mannheim

Mannheim, Germany

Location

Robert-Bosch Krankenhaus, Stuttgart

Stuttgart, Germany

Location

University Hospital Galway, CRFG

Galway, Ireland

Location

Gifu Heart Center

Gifu, Japan

Location

Ehime Medical University

Matsuyama, Japan

Location

Wakayama Medical University

Wakayama, 99999, Japan

Location

AMC Amsterdam

Amsterdam, Netherlands

Location

Amphia Ziekenhuis Breda

Breda, Netherlands

Location

Medische Spectrum Twente

Enschede, Netherlands

Location

Medisch Centrum Leeuwarden

Leeuwarden, Netherlands

Location

Sint Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Radboud UMC

Nijmegen, Netherlands

Location

Hospital Universitario de Léon

León, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Basildon Univeristy Hospital

Basildon, SS165NL, United Kingdom

Location

Blackpool Victoria hospital

Blackpool, United Kingdom

Location

Royal Bournemouth hospital

Bournemouth, BH7 7DW, United Kingdom

Location

Imperial College of London- Hammersmith Hospital

London, W12OHS, United Kingdom

Location

University of Southampton

Southampton, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 40081745 DERIVED

• 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.

  PMID: 39985510 DERIVED

• 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.

  PMID: 33992606 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Stenosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2018
• First Posted: February 28, 2019
• Study Start: August 1, 2019
• Primary Completion: March 12, 2021
• Study Completion: March 12, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Locations

IE (1); GB (5); ES (2); DE (4); NL (6); JP (3); US (19)