Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-03 @ 11:00 PM
Study NCT ID:
NCT03857503
Status:
COMPLETED
Last Update Posted:
2021-04-01
First Post:
2018-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 441}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-31', 'studyFirstSubmitDate': '2018-11-12', 'studyFirstSubmitQcDate': '2019-02-25', 'lastUpdatePostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic accuracy of the image-derived iFR', 'timeFrame': '1 day', 'description': 'Diagnostic accuracy of the image-derived iFR and FFR estimate for a given lesion compared to the corresponding invasive iFR and FFR values.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Ischemia', 'Coronary Artery Disease', 'Coronary Stenosis']}, 'referencesModule': {'references': [{'pmid': '40081745', 'type': 'DERIVED', 'citation': "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': '39985510', 'type': 'DERIVED', 'citation': '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': '33992606', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'This study is intended to demonstrate the diagnostic performance of the image-derived physiology model using the invasive physiological measures as the reference standard.\n\nSpecific objectives include the following:\n\ni) 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years old\n2. 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\n3. Able and willing to provide informed consent\n\nExclusion Criteria:\n\n1. Presenting with an acute coronary syndrome (ACS), or documented ACS within 4 weeks prior to the scheduled index procedure\n2. Cardiogenic shock (sustained (\\>10 min) systolic blood pressure \\<90 mmHg in absence of inotropic support or the presence of an intra-aortic balloon pump)\n3. Presence of cardiac arrhythmias (e.g., atrial fibrillation, AV-block)\n4. Prior cardiac surgery or implant, including CABG, heart transplant, surgical heart valve replacement or repair, TAVI/TAVR, presence of an ICD or pacemaker\n5. Target vessel supplied by a left main coronary artery demonstrating any disease present (isolated or non-isolated)\n6. Target vessel supplied by right coronary artery demonstrating any ostial disease (located immediately at the origin of the coronary vessels from the aorta)\n7. 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.\n8. Target vessel with severe tortuosity (≥1 bends of 90° or more, or ≥3 or more bends of 45°- 90° proximal to the diseased segment)\n9. 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.)\n10. Target vessel with TIMI flow grade 1 or 0\n11. 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)\n12. Target lesion is at a bifurcation/trifurcation\n13. Target arteries supplying akinetic or severely hypokinetic territories if already known based on prior imaging\n14. Target vessel is supplied by major collaterals\n15. Target stenosis associated with myocardial bridge\n16. Any vascular abnormality precluding optimal contrast opacification (e,g, thrombus, ulceration)\n17. Severe aortic or mitral valve disease\n18. Known ejection fraction ≤30%\n19. Known severe renal insufficiency (eGFR\\<30ml/min/1.72m2)\n20. Any fluoroscopic interference that renders the wire position unclear\n21. Contraindication for adenosine or other hyperemic agent (e.g., caffeine ingestion ≤18 hours, COPD, hypotension, AV block)\n22. Known pregnancy or planning to become pregnant\n23. Participating in another interventional investigational study'}, 'identificationModule': {'nctId': 'NCT03857503', 'acronym': 'ReVEAL', 'briefTitle': 'Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Volcano Corporation'}, 'officialTitle': 'Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)', 'orgStudyIdInfo': {'id': '180102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Lesion Assessment with iFR', 'description': '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.', 'interventionNames': ['Diagnostic Test: iFR']}], 'interventions': [{'name': 'iFR', 'type': 'DIAGNOSTIC_TEST', 'description': '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.\n\nAngiograms will be made in at least two projections, and the treating physician will record his/her estimation of stenosis severity.\n\nResting 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.', 'armGroupLabels': ['Coronary Lesion Assessment with iFR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90822', 'city': 'Long Beach', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 33.76696, 'lon': -118.18923}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': "Colorado Heart and Vascular/St Anthony's", 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33021', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Regional Hospital', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '33028', 'city': 'Pembroke Pines', 'state': 'Florida', 'country': 'United States', 'facility': 'Memorial Hospital- West', 'geoPoint': {'lat': 26.00315, 'lon': -80.22394}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '52803', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research Foundation', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension St. John Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '03102', 'city': 'Manchester', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Catholic Medical Center', 'geoPoint': {'lat': 42.99564, 'lon': -71.45479}}, {'zip': '11706', 'city': 'Bay Shore', 'state': 'New York', 'country': 'United States', 'facility': 'South Side Hospital', 'geoPoint': {'lat': 40.7251, 'lon': -73.24539}}, {'zip': '14203', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University at Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11576', 'city': 'Roslyn', 'state': 'New York', 'country': 'United States', 'facility': 'St Francis Hospital', 'geoPoint': {'lat': 40.79982, 'lon': -73.65096}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27607', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'NC Heart & Vascular', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '73112', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Integris Heart Hospital', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19010', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Bryn Mawr Hospital', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '19096', 'city': 'Wynnewood', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lankenau Medical Center', 'geoPoint': {'lat': 40.00289, 'lon': -75.27074}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Centennial Heart', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75246', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott & White Research Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Freiburg im Breisgau', 'country': 'Germany', 'facility': 'Unversitatklinikum, Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'city': 'Koblenz', 'country': 'Germany', 'facility': 'Gemeinschaftsklinikum, Koblenz', 'geoPoint': {'lat': 50.35357, 'lon': 7.57883}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': 'Universitatklinikum, Mannheim', 'geoPoint': {'lat': 49.4891, 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'Netherlands', 'facility': 'Medische Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}, {'city': 'Leeuwarden', 'country': 'Netherlands', 'facility': 'Medisch Centrum Leeuwarden', 'geoPoint': {'lat': 53.20271, 'lon': 5.80973}}, {'city': 'Nieuwegein', 'country': 'Netherlands', 'facility': 'Sint Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud UMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'León', 'country': 'Spain', 'facility': 'Hospital Universitario de Léon', 'geoPoint': {'lat': 42.60003, 'lon': -5.57032}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Clinico San Carlos', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': 'SS165NL', 'city': 'Basildon', 'country': 'United Kingdom', 'facility': 'Basildon Univeristy Hospital', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}, {'city': 'Blackpool', 'country': 'United Kingdom', 'facility': 'Blackpool Victoria hospital', 'geoPoint': {'lat': 53.81667, 'lon': -3.05}}, {'zip': 'BH7 7DW', 'city': 'Bournemouth', 'country': 'United Kingdom', 'facility': 'Royal Bournemouth hospital', 'geoPoint': {'lat': 50.72048, 'lon': -1.8795}}, {'zip': 'W12OHS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College of London- Hammersmith Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'University of Southampton', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Volcano Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}