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| Name | Class |
|---|---|
| Medis Medical Imaging Systems | UNKNOWN |
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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.
Patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (CAG). Lesions are often quantified by visual assessment of the angiogram, but physiological assessment of the functional significance by fractional flow reserve has been shown to improve clinical outcome, to reduce number of stents implanted, and has obtained the highest recommendation in European guidelines. FFR is assessed during CAG by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during medical induced maximum blood flow (hyperaemia).
The solid evidence for FFR evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an FFR based strategy but the need for interrogating the stenosis by a pressure wire, the small risks associated hereto, the cost of the wire, and the drug inducing hyperaemia has limited more widespread adoption.
Quantitative Flow Ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on computation of two angiographic projections.
Two multi-center studies, the FAVOR II Europe-Japan and China studies evaluated the feasibility and diagnostic performance of in-procedure QFR, showing very good agreement between QFR and FFR.
The purpose of the FAVOR III Europe Japan study is to investigate if a QFR-based diagnostic strategy yields non-inferior 12-month clinical outcome compared to a standard pressure-wire guided strategy in evaluation of patients with stable angina pectoris and intermediate coronary stenosis.
Primary hypothesis: A QFR based diagnostic strategy results in non-inferior clinical outcome, assessed by a composite endpoint of all cause death, non-fatal myocardial infarction (MI) and unplanned revascularization after one year, compared to a strategy of pressure wire-based FFR for assessment of physiological significance of intermediate coronary artery stenosis.
Methods: Investigator initiated, 1:1 randomized, prospective, clinical outcome, non-inferiority, multi-center trial performed at up to 40 international sites with inclusion of 2000 patients.
Patients with stable angina pectoris or need for evaluation of non-culprit lesions after acute MI are enrolled. At least two angiographic projections are acquired during resting conditions. If the angiographic criteria are met, the patient is randomized to either a QFR- or an FFR-based diagnostic strategy.
Revascularization is performed according to best standard by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).
Patient follow-up is continued until 24 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QFR-based diagnostic strategy | Diagnostic Test | Novel computer based calculation of lesion severity. Pressure wire-free and adenosine-free |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient oriented composite endpoint (PoCE) | A composite endpoint of 1) all-cause mortality, 2) any myocardial infarction, and 3) any unplanned revascularization | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure | A composite of cardiac death, target vessel myocardial infarction and ischemic driven target vessel revascularization. | 1 month |
| Target vessel failure | A composite of cardiac death, target vessel myocardial infarction and ischemic driven target vessel revascularization. |
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Inclusion Criteria:
Angiographic inclusion criteria
Exclusion Criteria:
Angiographic exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Evald H. Christiansen, Prof. | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Aalborg | 9100 | Denmark | |||
| Aarhus University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27712739 | Background | 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. | |
| 29980523 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 20, 2025 | |
| Reset | Dec 3, 2025 |
Randomized clinical non-inferiority trial
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| 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 |
|
| 12 months |
| Target vessel failure | A composite of cardiac death, target vessel myocardial infarction and ischemic driven target vessel revascularization. | 24 months |
| All-cause mortality | Total death includes cardiac death and other fatal categories such as cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurism will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons. | 1 month |
| All-cause mortality | Total death includes cardiac death and other fatal categories such as cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurism will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons. | 12 months |
| All-cause mortality | Total death includes cardiac death and other fatal categories such as cerebrovascular death, death from other cardiovascular disease (i.e. pulmonary embolism, dissection aortic aneurism will be included in this category), death from malignant disease, death from suicide, violence or accident, or death from other reasons. | 24 months |
| Cardiac death | Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death | 1 month |
| Cardiac death | Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death | 12 months |
| Cardiac death | Encompasses death due to coronary heart disease including fatal myocardial infarction, sudden cardiac death including fatal arrhythmias and cardiac arrest without successful resuscitation, death from heart failure including cardiogenic shock, and death related the cardiac procedure within 28 days from the procedure. If death is not clearly attributable to other non-cardiac causes it is adjudicated as cardiac death | 24 months |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction. Protocol defined. | 1 month |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction. Protocol defined. | 12 months |
| Myocardial infarction | Procedure and non-procedure related myocardial infarction. Protocol defined. | 24 months |
| Target vessel myocardial infarction | As "any myocardial infarction", but with culprit lesion in index vessel. | 1 month |
| Target vessel myocardial infarction | As "any myocardial infarction", but with culprit lesion in index vessel. | 12 months |
| Target vessel myocardial infarction | As "any myocardial infarction", but with culprit lesion in index vessel. | 24 months |
| Any unplanned revascularization | Coronary artery bypass grafting (CABG) or PCI of any lesion. Planned Revascularization: Revascularization is considered planned when it is decided at the time of the index procedure, based on the results of angiography and functional testing. Planned revascularization could be performed at the time of the index procedure or within 60 days. Such revascularization is considered as "primary" revascularization and is not considered as an endpoint. The "planned" status of the revascularization is adjudicated. Unplanned Revascularization: Revascularization is considered "unplanned" when not performed as part of standard care during the index procedure or if it is not planned as a staged procedure to occur within 60 days. | 1 month |
| Any unplanned revascularization | Coronary artery bypass grafting (CABG) or PCI of any lesion. Planned Revascularization: Revascularization is considered planned when it is decided at the time of the index procedure, based on the results of angiography and functional testing. Planned revascularization could be performed at the time of the index procedure or within 60 days. Such revascularization is considered as "primary" revascularization and is not considered as an endpoint. The "planned" status of the revascularization is adjudicated. Unplanned Revascularization: Revascularization is considered "unplanned" when not performed as part of standard care during the index procedure or if it is not planned as a staged procedure to occur within 60 days. | 12 months |
| Any unplanned revascularization | Coronary artery bypass grafting (CABG) or PCI of any lesion. Planned Revascularization: Revascularization is considered planned when it is decided at the time of the index procedure, based on the results of angiography and functional testing. Planned revascularization could be performed at the time of the index procedure or within 60 days. Such revascularization is considered as "primary" revascularization and is not considered as an endpoint. The "planned" status of the revascularization is adjudicated. Unplanned Revascularization: Revascularization is considered "unplanned" when not performed as part of standard care during the index procedure or if it is not planned as a staged procedure to occur within 60 days. | 24 months |
| Any ischemia driven de novo revascularization | Coronary artery bypass grafting or PCI of a vessel that was not evaluated nor treated during the index procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 1 month |
| Any ischemia driven de novo revascularization | Coronary artery bypass grafting or PCI of a vessel that was not evaluated nor treated during the index procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 12 months |
| Any ischemia driven de novo revascularization | Coronary artery bypass grafting or PCI of a vessel that was not evaluated nor treated during the index procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 24 months |
| Ischemia driven target vessel revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 1 month |
| Ischemia driven target vessel revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 12 months |
| Ischemia driven target vessel revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 24 months |
| Ischemia driven treated target lesion revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia that was treated during index or planned staged procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 1 month |
| Ischemia driven treated target lesion revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia that was treated during index or planned staged procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 12 months |
| Ischemia driven treated target lesion revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel with documented ischemia that was treated during index or planned staged procedure. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI | 24 months |
| Ischemia driven, measured segment revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI. | 1 month |
| Ischemia driven, measured segment revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR (both treated and not treated). In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI. | 12 months |
| Ischemia driven, measured segment revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI. | 24 months |
| Ischemia driven measured segment de novo revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI. | 1 month |
| Ischemia driven measured segment de novo revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI. | 12 months |
| Ischemia driven measured segment de novo revascularization | Coronary artery bypass grafting (CABG) or PCI of a study vessel that was evaluated by either FFR or QFR but not treated. In stable patients, ischemia should always be documented, using for example FFR, SPECT scan or MRI. | 24 months |
| Feasibility of QFR | Percentage of successful QFR in patients allocated to a QFR based diagnostic strategy | 1 hour |
| Feasibility of FFR | Percentage of successfully performed FFR measurements in vessels with attempted FFR (vessel level) Percentages of patients with successful FFR measurements (all attempted) | 1 hour |
| Number of lesion interrogated | Total number of lesions diagnosed with either QFR or FFR during the procedure | 1 hour |
| Procedure time | Time from introduction of the sheet until the sheet for coronary access is removed from the patient | 1 hour |
| Contrast volume | Total volume of contrast used in the procedure | 1 hour |
| Fluoroscopy time | Total fluoroscopy time for the procedure | 1 hour |
| Number of stents implanted | Total number of stents implanted during the procedure. Stents implanted in a staged procedure are included | 1 hour |
| Aarhus N |
| 8000 |
| Denmark |
| Gentofte Hospital | Hellerup | 2900 | Denmark |
| Institut Arnault Tzanck | Saint-Laurent-du-Var | Nice | 06700 | France |
| GCS ES Axium - Parc Rambot | Aix-en-Provence | 13097 | France |
| CHU de Lille, Lille University Hospital | Lille | 59000 | France |
| Institut Cardiovasculaire Paris Sud (ICPS), Hopital Jacques Cartier | Massy | 91300 | France |
| Hopital Haut-Leveque, Pessac | Pessac | 33600 | France |
| Hôpital Privé Claude Galien | Quincy | 91480 | France |
| Clinique Pasteur, Toulouse | Toulouse | 31076 | France |
| Charite-Universitatsmedizin Berlin | Berlin | 12200 | Germany |
| Elisabeth Krankenhaus | Essen | 45138 | Germany |
| University Clinic Leipzig | Leipzig | 04103 | Germany |
| Ospedale Maggiore, AUSL Bologna | Bologna | 40133 | Italy |
| Azienda Ospedaliero-Universitaria di Ferrara, University of Ferrara | Ferrara | 44124 | Italy |
| Azienda Ospedaliero Universitaria Federico II di Napoli | Naples | 80138 | Italy |
| San Luigi Gonzaga University Hospital, Turin | Orbassano | 10043 | Italy |
| Arcispedale S. Maria Nuova di Reggio Emilia | Reggio Emilia | 42123 | Italy |
| Ospedale degli Infermi di Rimini | Rimini | 47923 | Italy |
| Ospedale di Rivoli, Torino | Torino | 10098 | Italy |
| Azienda Ospedaliera Universitaria integrata Verona | Verona | 37126 | Italy |
| Riga Stradini University Hospital | Riga | 1002 | Latvia |
| Hospital of Lithuanian University of Health Sciences Kauno Klinikos | Kaunas | 50161 | Lithuania |
| VU University Medical Center | Amsterdam | 1081 | Netherlands |
| Academic Medical Center (AMC) | Amsterdam | 1105 | Netherlands |
| HagaZiekenhuis | The Hague | 2545 | Netherlands |
| Medical University of Warsaw | Warsaw | PL 02-097 | Poland |
| Hospital Clinico Universitario Virgen de la Arrixaca | El Palmar | Murcia | 30120 | Spain |
| Hospital Clinico de Coruña | A Coruña | 15006 | Spain |
| Hospital Lucus Agusti LUGO | Lugo | 27003 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Clinico Universitario de Valladolid | Valladolid | 47003 | Spain |
| Hospital Álvaro Cunqueiro | Vigo | 36312 | Spain |
| Sahlgrenska University Hospital | Gothenburg | 413 45 | Sweden |
| Barbera Stähli | Zurich | Zûrich | 8091 | Switzerland |
| 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. |
| 29555835 | 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. |
| 29101020 | 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. |
| 39488224 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 20, 2025 | Dec 3, 2025 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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