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

Completed

Conditions studied: Cardiac Ischemia, Coronary Artery Disease, Coronary Stenosis

In brief

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.

Key facts

Study ID

NCT03857503

Run by

Volcano Corporation

People needed

441

Starts

2019-08-01

Expected to finish

2021-03-12

Last updated by the study team

2021-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Any vascular abnormality precluding optimal contrast opacification (e,g, thrombus, ulceration)
• Severe aortic or mitral valve disease
• Known ejection fraction ≤30%
• Known severe renal insufficiency (eGFR<30ml/min/1.72m2)
• Any fluoroscopic interference that renders the wire position unclear
• Contraindication for adenosine or other hyperemic agent (e.g., caffeine ingestion ≤18 hours, COPD, hypotension, AV block)
• Known pregnancy or planning to become pregnant
• Participating in another interventional investigational study

Where it is running

• 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

Full record on ClinicalTrials.gov

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