NCT03729739

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

Active, enrolled NA Last updated 24 July 2024

What this trial tests

NA trial testing QFR-based diagnostic strategy in Coronary Artery Disease in 2,001 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

6 November 2018

Primary endpoint
21 July 2023

31 December 2025

Quick facts

Lead sponsor	Aarhus University Hospital Skejby
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	diagnostic
Enrollment	2,001
Start date	6 November 2018
Primary completion	21 July 2023
Estimated completion	31 December 2025
Sites	35 locations across Denmark, France, Italy, Netherlands, Sweden, Germany, Poland, Lithuania

Drugs / interventions tested

• QFR-based diagnostic strategy
• FFR-based diagnostic strategy

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Aarhus University Hospital Skejby

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Quantitative flow ratio versus fractional flow reserve for coronary revascularisation guidance (FAVOR III Europe): a multicentre, randomised, non-inferiority trial.
   Andersen BK, Sejr-Hansen M, Maillard L, Campo G, et al · · 2024 · cited 61× · PMID 39488224 · DOI 10.1016/s0140-6736(24)02175-5
2. Reproducibility of quantitative flow ratio: the QREP study.
   Westra J, Sejr-Hansen M, Koltowski L, Mejía-Rentería H, et al · · 2022 · cited 37× · PMID 34219667 · DOI 10.4244/eij-d-21-00425
3. Current and Future Applications of Computational Fluid Dynamics in Coronary Artery Disease.
   Candreva A, De Nisco G, Lodi Rizzini M, D'Ascenzo F, et al · · 2022 · cited 30× · PMID 39076179 · DOI 10.31083/j.rcm2311377
4. Functional coronary angiography for the assessment of the epicardial vessels and the microcirculation.
   Faria D, Hennessey B, Shabbir A, Mejía-Rentería H, et al · · 2023 · cited 27× · PMID 37326378 · DOI 10.4244/eij-d-22-00969
5. Angiography-Based Fractional Flow Reserve: State of the Art.
   Scoccia A, Tomaniak M, Neleman T, Groenland FTW, et al · · 2022 · cited 27× · PMID 35435570 · DOI 10.1007/s11886-022-01687-4
6. Impact of physiologically diffuse versus focal pattern of coronary disease on quantitative flow reserve diagnostic accuracy.
   Scarsini R, Fezzi S, Pesarini G, Del Sole PA, et al · · 2022 · cited 27× · PMID 34761492 · DOI 10.1002/ccd.30007
7. Quantitative flow ratio versus fractional flow reserve for guiding percutaneous coronary intervention: design and rationale of the randomised FAVOR III Europe Japan trial.
   Andersen BK, Sejr-Hansen M, Westra J, Campo G, et al · · 2023 · cited 24× · PMID 36648404 · DOI 10.4244/eij-d-21-00214
8. Outcomes of quantitative flow ratio-based percutaneous coronary intervention in an all-comers study.
   Zhang R, Dou K, Guan C, Zou T, et al · · 2022 · cited 19× · PMID 34219669 · DOI 10.4244/eij-d-21-00176