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Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Trial
Sponsor: Aarhus University Hospital Skejby
Summary
Quantitative Flow Ratio (QFR) is a novel method for evaluating the functional significance of coronary stenosis. QFR is estimated based on two angiographic projections. Studies have shown a good correlation with the present wire-based standard approach Fractional Flow Reserve (FFR) for assessment of intermediate coronary stenosis. The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy will results in non-inferior clinical outcome after 12 months compared to a standard pressure-wire guided strategy in evaluation of patients with chest pain (stable angina pectoris) and intermediate coronary stenosis.
Official title: Comparison of Quantitative Flow Ratio (QFR) and Conventional Pressure-wire Based Functional Evaluation for Guiding Coronary Intervention. A Randomized Clinical Non-inferiority Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
2001
Start Date
2018-11-06
Completion Date
2025-12-31
Last Updated
2024-07-24
Healthy Volunteers
No
Conditions
Interventions
QFR-based diagnostic strategy
Novel computer based calculation of lesion severity. Pressure wire-free and adenosine-free
FFR-based diagnostic strategy
Standard FFR based diagnostic method. Pressure drop across the stenosis is measured with a pressure wire during medical induced hyperaemic conditions
Locations (35)
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus N, Denmark
Gentofte Hospital
Hellerup, Denmark
Institut Arnault Tzanck
Saint-Laurent-du-Var, Nice, France
GCS ES Axium - Parc Rambot
Aix-en-Provence, France
CHU de Lille, Lille University Hospital
Lille, France
Institut Cardiovasculaire Paris Sud (ICPS), Hopital Jacques Cartier
Massy, France
Hopital Haut-Leveque, Pessac
Pessac, France
Hôpital Privé Claude Galien
Quincy, France
Clinique Pasteur, Toulouse
Toulouse, France
Charite-Universitatsmedizin Berlin
Berlin, Germany
Elisabeth Krankenhaus
Essen, Germany
University Clinic Leipzig
Leipzig, Germany
Ospedale Maggiore, AUSL Bologna
Bologna, Italy
Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara
Ferrara, Italy
Azienda Ospedaliero Universitaria Federico II di Napoli
Naples, Italy
San Luigi Gonzaga University Hospital, Turin
Orbassano, Italy
Arcispedale S. Maria Nuova di Reggio Emilia
Reggio Emilia, Italy
Ospedale degli Infermi di Rimini
Rimini, Italy
Ospedale di Rivoli, Torino
Torino, Italy
Azienda Ospedaliera Universitaria integrata Verona
Verona, Italy
Riga Stradini University Hospital
Riga, Latvia
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Kaunas, Lithuania
VU University Medical Center
Amsterdam, Netherlands
Academic Medical Center (AMC)
Amsterdam, Netherlands
HagaZiekenhuis
The Hague, Netherlands
Medical University of Warsaw
Warsaw, Poland
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Hospital Clinico de Coruña
A Coruña, Spain
Hospital Lucus Agusti LUGO
Lugo, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
Hospital Álvaro Cunqueiro
Vigo, Spain
Sahlgrenska University Hospital
Gothenburg, Sweden
Barbera Stähli
Zurich, Zûrich, Switzerland