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

NCT03729739 | Active Not Recruiting DMC

• 1 other identifier: 1-10-72-263-18
• Study Type: interventional
• Target: 2,001
• Locations: 11 countries
• Sites: 35

Brief 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.

Conditions

Coronary Artery Disease

Keywords

Fractional Flow Reserve (FFR); Quantitative Flow Ratio (QFR); Stable coronary artery disease; Angina pectoris; Angiography derived fractional flow reserve

Outcome Measures

Primary Outcomes (1)

• Patient oriented composite endpoint (PoCE)

  A composite endpoint of 1) all-cause mortality, 2) any myocardial infarction, and 3) any unplanned revascularization

  12 months

Secondary Outcomes (40)

• Target vessel failure

  1 month

• Target vessel failure

  12 months

• Target vessel failure

  24 months

• All-cause mortality

  1 month

• All-cause mortality

  12 months

Study Arms (2)

QFR-based diagnostic strategy

EXPERIMENTAL

Intermediate stenosis with indication for evaluation are diagnosed by Quantitative flow ratio (QFR). Revascularization is indicated if QFR≤0.80. Treatment is performed according to standard clinical practice.

Diagnostic Test: QFR-based diagnostic strategy

FFR-based diagnostic strategy

ACTIVE COMPARATOR

Intermediate stenosis with indication for evaluation are diagnosed by fractional flow reserve (FFR). Revascularization is indicated if FFR≤0.80. Treatment is performed according to standard clinical practice.

Diagnostic Test: FFR-based diagnostic strategy

Interventions

QFR-based diagnostic strategy DIAGNOSTIC_TEST

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

QFR-based diagnostic strategy

FFR-based diagnostic strategy DIAGNOSTIC_TEST

Standard FFR based diagnostic method. Pressure drop across the stenosis is measured with a pressure wire during medical induced hyperaemic conditions

FFR-based diagnostic strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 18 years and above
• Both genders
• Indication for invasive coronary angiography
• Patients with stable angina pectoris, or assessment of secondary lesions in stabilized non-STEMI patients or assessment of secondary lesions in patients with prior STEMI and staged evaluation of secondary lesions.
• Able to provide written informed consent
• Diameter stenosis of 40-90% diameter stenosis
• Vessel diameter of at least 2.5 mm and supplying viable myocardium
• Patients with restenosis in a native coronary artery can be included

You may not qualify if:

• Severely impaired renal function: Glomerular filtration rate (GFR) \< 20 mL/min/1.73m²
• Life expectancy less than one year
• Cardiogenic shock or unstable haemodynamic state (Killip class III and IV)
• ST-elevation myocardial infarction (STEMI) within 24 hours
• Bypass graft to any target vessel
• Atrial fibrillation at the time of the procedure
• Chronic total occlusions of any vessel with possible or established indication for treatment
• Pregnancy or intention to become pregnant during the course of the trial
• Breast feeding
• Planned need for concomitant valvular or aortic surgery
• Left ventricular ejection fraction (LVEF) \< 30%
• Enrolled in another clinical study, and for this reason not treated according to present European Society of Cardiology guidelines, or the protocol treatment conflicts with the protocol treatment of FAVOR III
• Inability to tolerate contrast media
• Inability to tolerate Adenosine
• Ostial right coronary artery \> 50% diameter stenosis

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead
• Medis Medical Imaging Systems: collaborator

Study Sites (35)

Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Aarhus University Hospital

Aarhus N, 8000, Denmark

Location

Gentofte Hospital

Hellerup, 2900, Denmark

Location

Institut Arnault Tzanck

Saint-Laurent-du-Var, Nice, 06700, France

Location

GCS ES Axium - Parc Rambot

Aix-en-Provence, 13097, France

Location

CHU de Lille, Lille University Hospital

Lille, 59000, France

Location

Institut Cardiovasculaire Paris Sud (ICPS), Hopital Jacques Cartier

Massy, 91300, France

Location

Hopital Haut-Leveque, Pessac

Pessac, 33600, France

Location

Hôpital Privé Claude Galien

Quincy, 91480, France

Location

Clinique Pasteur, Toulouse

Toulouse, 31076, France

Location

Charite-Universitatsmedizin Berlin

Berlin, 12200, Germany

Location

Elisabeth Krankenhaus

Essen, 45138, Germany

Location

University Clinic Leipzig

Leipzig, 04103, Germany

Location

Ospedale Maggiore, AUSL Bologna

Bologna, 40133, Italy

Location

Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara

Ferrara, 44124, Italy

Location

Azienda Ospedaliero Universitaria Federico II di Napoli

Naples, 80138, Italy

Location

San Luigi Gonzaga University Hospital, Turin

Orbassano, 10043, Italy

Location

Arcispedale S. Maria Nuova di Reggio Emilia

Reggio Emilia, 42123, Italy

Location

Ospedale degli Infermi di Rimini

Rimini, 47923, Italy

Location

Ospedale di Rivoli, Torino

Torino, 10098, Italy

Location

Azienda Ospedaliera Universitaria integrata Verona

Verona, 37126, Italy

Location

Riga Stradini University Hospital

Riga, 1002, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, 50161, Lithuania

Location

VU University Medical Center

Amsterdam, 1081, Netherlands

Location

Academic Medical Center (AMC)

Amsterdam, 1105, Netherlands

Location

HagaZiekenhuis

The Hague, 2545, Netherlands

Location

Medical University of Warsaw

Warsaw, PL 02-097, Poland

Location

Hospital Clinico Universitario Virgen de la Arrixaca

El Palmar, Murcia, 30120, Spain

Location

Hospital Clinico de Coruña

A Coruña, 15006, Spain

Location

Hospital Lucus Agusti LUGO

Lugo, 27003, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, 36312, Spain

Location

Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Barbera Stähli

Zurich, Zûrich, 8091, Switzerland

Location

Related Publications (5)

• Tu S, Westra J, Yang J, von Birgelen C, Ferrara A, Pellicano M, Nef H, Tebaldi M, Murasato Y, Lansky A, Barbato E, van der Heijden LC, Reiber JHC, Holm NR, Wijns W; FAVOR Pilot Trial Study Group. Diagnostic Accuracy of Fast Computational Approaches to Derive Fractional Flow Reserve From Diagnostic Coronary Angiography: The International Multicenter FAVOR Pilot Study. JACC Cardiovasc Interv. 2016 Oct 10;9(19):2024-2035. doi: 10.1016/j.jcin.2016.07.013.

  PMID: 27712739 BACKGROUND

• Westra J, Andersen BK, Campo G, Matsuo H, Koltowski L, Eftekhari A, Liu T, Di Serafino L, Di Girolamo D, Escaned J, Nef H, Naber C, Barbierato M, Tu S, Neghabat O, Madsen M, Tebaldi M, Tanigaki T, Kochman J, Somi S, Esposito G, Mercone G, Mejia-Renteria H, Ronco F, Botker HE, Wijns W, Christiansen EH, Holm NR. Diagnostic Performance of In-Procedure Angiography-Derived Quantitative Flow Reserve Compared to Pressure-Derived Fractional Flow Reserve: The FAVOR II Europe-Japan Study. J Am Heart Assoc. 2018 Jul 6;7(14):e009603. doi: 10.1161/JAHA.118.009603.

  PMID: 29980523 BACKGROUND

• Westra J, Tu S, Winther S, Nissen L, Vestergaard MB, Andersen BK, Holck EN, Fox Maule C, Johansen JK, Andreasen LN, Simonsen JK, Zhang Y, Kristensen SD, Maeng M, Kaltoft A, Terkelsen CJ, Krusell LR, Jakobsen L, Reiber JHC, Lassen JF, Bottcher M, Botker HE, Christiansen EH, Holm NR. Evaluation of Coronary Artery Stenosis by Quantitative Flow Ratio During Invasive Coronary Angiography: The WIFI II Study (Wire-Free Functional Imaging II). Circ Cardiovasc Imaging. 2018 Mar;11(3):e007107. doi: 10.1161/CIRCIMAGING.117.007107.

  PMID: 29555835 BACKGROUND

• Xu B, Tu S, Qiao S, Qu X, Chen Y, Yang J, Guo L, Sun Z, Li Z, Tian F, Fang W, Chen J, Li W, Guan C, Holm NR, Wijns W, Hu S. Diagnostic Accuracy of Angiography-Based Quantitative Flow Ratio Measurements for Online Assessment of Coronary Stenosis. J Am Coll Cardiol. 2017 Dec 26;70(25):3077-3087. doi: 10.1016/j.jacc.2017.10.035. Epub 2017 Oct 31.

  PMID: 29101020 BACKGROUND

• Andersen BK, Sejr-Hansen M, Maillard L, Campo G, Ramunddal T, Stahli BE, Guiducci V, Serafino LD, Escaned J, Santos IA, Lopez-Palop R, Landmesser U, Dieu RS, Mejia-Renteria H, Koltowski L, Ziubryte G, Cetran L, Adjedj J, Abdelwahed YS, Liu T, Mogensen LJH, Eftekhari A, Westra J, Lenk K, Casella G, Van Belle E, Biscaglia S, Olsen NT, Knaapen P, Kochman J, Santos RC, Scarsini R, Christiansen EH, Holm NR. Quantitative flow ratio versus fractional flow reserve for coronary revascularisation guidance (FAVOR III Europe): a multicentre, randomised, non-inferiority trial. Lancet. 2024 Nov 9;404(10465):1835-1846. doi: 10.1016/S0140-6736(24)02175-5. Epub 2024 Oct 30.

  PMID: 39488224 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina Pectoris

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Evald H. Christiansen, Prof.

  Aarhus University Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant cardiologist, Associate professor

Model Details: Randomized clinical non-inferiority trial

Study Record Dates

• First Submitted: November 1, 2018
• First Posted: November 5, 2018
• Study Start: November 6, 2018
• Primary Completion: July 21, 2023
• Study Completion: December 31, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

DE (3); DK (3); LA (1); FR (7); NL (3); IT (8); PL (1); LI (1); CH (1); ES (6); SE (1)