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

Completed

• Conditions: Coronary Artery Disease; Coronary Stenosis; Cardiac Ischemia
• Interventions: Diagnostic Test: iFR

• Registration Number: NCT03857503
• Lead Sponsor: Volcano Corporation

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.

Study Timeline

• Study First Submitted: 2018-11-12
• Study First Submitted QC: 2019-02-25
• Study First Posted: 2019-02-28
• Study Start: 2019-08-01
• Status Verified: 2021-03
• Primary Completion: 2021-03-12
• Study Completion: 2021-03-12
• Last Update Submitted: 2021-03-31
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 441

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary Lesion Assessment with iFR	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of the image-derived iFR	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.

Trial Locations

Locations (40)

Midwest Cardiovascular Research Foundation; 🇺🇸 Davenport, Iowa, 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

NC Heart & Vascular; 🇺🇸 Goldsboro, North Carolina, United States

Bryn Mawr Hospital; 🇺🇸 Wynnewood, Pennsylvania, United States

Lankenau Medical Center; 🇺🇸 Wynnewood, Pennsylvania, United States

Gemeinschaftsklinikum, Koblenz; 🇩🇪 Koblenz, Germany

Universitatklinikum, Mannheim; 🇩🇪 Mannheim, Germany

Robert-Bosch Krankenhaus, Stuttgart; 🇩🇪 Stuttgart, Germany

University Hospital Galway, CRFG; 🇮🇪 Galway, Ireland

Amphia Ziekenhuis Breda; 🇳🇱 Breda, Netherlands

Sint Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Hospital Universitario de Léon; 🇪🇸 León, Spain

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Basildon Univeristy Hospital; 🇬🇧 Basildon, United Kingdom

Imperial College of London- Hammersmith Hospital; 🇬🇧 London, United Kingdom

University of Southampton; 🇬🇧 Southampton, United Kingdom

Blackpool Victoria hospital; 🇬🇧 Blackpool, United Kingdom

Royal Bournemouth hospital; 🇬🇧 Bournemouth, United Kingdom

Colorado Heart and Vascular/St Anthony's; 🇺🇸 Lakewood, Colorado, United States

Gifu Heart Center; 🇯🇵 Gifu, Japan

Ehime Medical University; 🇯🇵 Matsuyama, Japan

Medische Spectrum Twente; 🇳🇱 Enschede, Netherlands

Medisch Centrum Leeuwarden; 🇳🇱 Leeuwarden, Netherlands

VA Medical Center; 🇺🇸 Long Beach, California, United States

Wakayama Medical University; 🇯🇵 Wakayama, Japan

Unversitatklinikum, Freiburg; 🇩🇪 Freiburg, Germany

AMC Amsterdam; 🇳🇱 Amsterdam, Netherlands

Radboud UMC; 🇳🇱 Nijmegen, Netherlands

Yale University Hospital; 🇺🇸 New Haven, Connecticut, United States

Memorial Regional Hospital; 🇺🇸 Hollywood, Florida, United States

Memorial Hospital- West; 🇺🇸 Pembroke Pines, Florida, United States

Integris Heart Hospital; 🇺🇸 Oklahoma City, Oklahoma, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Ascension St. John Hospital; 🇺🇸 Detroit, Michigan, United States

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States

Centennial Heart; 🇺🇸 Nashville, Tennessee, United States

Baylor Scott & White Research Institute; 🇺🇸 Dallas, Texas, United States