Clinical trial NCT03857503: Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
Official title: Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Ischemia
Coronary Artery Disease
Coronary Stenosis
Lead sponsor: Volcano Corporation
Sponsor class: INDUSTRY
First posted: 2019-02-28
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diagnostic accuracy of the image-derived iFR
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Medical Center
state: California
city: Lakewood
country: United States
facility: Colorado Heart and Vascular/St Anthony's
state: Colorado
city: New Haven
country: United States
facility: Yale University Hospital
state: Connecticut
city: Hollywood
country: United States
facility: Memorial Regional Hospital
state: Florida
city: Pembroke Pines
country: United States
facility: Memorial Hospital- West
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Detroit
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: Bay Shore
country: United States
facility: South Side Hospital
state: New York
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
city: Roslyn
country: United States
facility: St Francis Hospital
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Goldsboro
country: United States
facility: NC Heart & Vascular
state: North Carolina
city: Oklahoma City
country: United States
facility: Integris Heart Hospital
state: Oklahoma
city: Wynnewood
country: United States
facility: Bryn Mawr Hospital
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Nashville
country: United States
facility: Centennial Heart
state: Tennessee
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Freiburg
country: Germany
facility: Unversitatklinikum, Freiburg
city: Koblenz
country: Germany
facility: Gemeinschaftsklinikum, Koblenz
city: Mannheim
country: Germany
facility: Universitatklinikum, Mannheim
city: Stuttgart
country: Germany
facility: Robert-Bosch Krankenhaus, Stuttgart
city: Galway
country: Ireland
facility: University Hospital Galway, CRFG
city: Gifu
country: Japan
facility: Gifu Heart Center
city: Matsuyama
country: Japan
facility: Ehime Medical University
city: Wakayama
country: Japan
facility: Wakayama Medical University
city: Amsterdam
country: Netherlands
facility: AMC Amsterdam
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis Breda
city: Enschede
country: Netherlands
facility: Medische Spectrum Twente
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Nieuwegein
country: Netherlands
facility: Sint Antonius Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: León
country: Spain
facility: Hospital Universitario de Léon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Basildon
country: United Kingdom
facility: Basildon Univeristy Hospital
city: Blackpool
country: United Kingdom
facility: Blackpool Victoria hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth hospital
city: London
country: United Kingdom
facility: Imperial College of London- Hammersmith Hospital
city: Southampton
country: United Kingdom
facility: University of Southampton
Study officials:
References:
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.