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ACTIVE NOT RECRUITING
NCT03729739
NA

Functional Assessment by Virtual Online Reconstruction. The FAVOR III Europe Trial

Sponsor: Aarhus University Hospital Skejby

View on ClinicalTrials.gov

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

Interventions

DIAGNOSTIC_TEST

QFR-based diagnostic strategy

Novel computer based calculation of lesion severity. Pressure wire-free and adenosine-free

DIAGNOSTIC_TEST

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