August 10th, 2021

ECRI announces the FAST III multicenter clinical trial to determine the effectiveness of vFFR-guided revascularization compared with invasive FFR-guided revascularization in patients with intermediate coronary lesions

Rotterdam, the Netherlands – the European Cardiovascular Research Institute (ECRI) announced today a multicenter European clinical trial which plans to investigate the use of angiography-based fractional flow reserve calculated by means of vessel-Fractional Flow Reserve software (CAAS vFFR, Pie Medical, The Netherlands) in patients undergoing coronary revascularization procedures. vFFR can assess whether a coronary artery narrowing is functionally severe and requires treatment, or not.

Assessment of coronary narrowing severity with physiology-based techniques is currently endorsed by European Guidelines on Myocardial Revascularization, and the use of invasive catheters to measure pressure gradient (FFR catheters) is part of routine practice. More recently, methods based only on angiographic projections (without the need of additional catheters) have been developed and their accuracy validated against invasive FFR.

The diagnostic accuracy of vFFR was validated in the Fast Assessment of STenosis severity (FAST) study, which showed that vFFR was highly correlated to pressure-wired-based FFR, had a high diagnostic accuracy,  and a low inter-observer variability. Further evidence on the use of vFFR was recently presented at Euro PCR 2021 as a Late Breaking Clinical Trial. The FAST II study, which included measurements by a blinded Core Lab, showed a good correlation between Core Lab vFFR and pressure wire-based FFR. vFFR had an excellent diagnostic accuracy in identifying lesions compared with an invasive wire-based FFR.

The Fractional Flow Reserve or 3D-Quantitative-Coronary-Angiography Based Vessel-FFR guided revascularization (FAST III) trial, is a randomized controlled, open-label, multicenter, international, non-inferiority, strategy trial (NCT04931771). A total of 2228 participants will be randomized in a 1:1 fashion to either vFFR- or FFR-guided revascularization. This outcome trial plans to enroll participants in 35 sites and 7 European countries (Netherlands, Ireland, United Kingdom, Germany, Italy, Spain, and France), and report its primary endpoint once all participants have completed 12 months of follow-up.

The study is overseen by a panel of renowned experts in cardiovascular research, including Dr. Joost Daemen, Principal Investigator of the FAST III trial (Erasmus Medical Center, Rotterdam, the Netherlands), Prof. Robert Byrne (Mater Private Hospital, Dublin, Ireland), Prof. Adrian Banning (John Radcliffe Hospital, Oxford, United Kingdom), Prof. Ulf Landmesser (Charite Hospital, Berlin, Germany), Prof. Jan Tijssen (ECRI, Rotterdam, the Netherlands) and Dr. Ernest Spitzer (ECRI, Rotterdam, the Netherlands), as sponsor representative.

The trial is sponsored by ECRI and funded by research grants from Pie Medical Imaging (Maastricht, the Netherlands) and Siemens Healthineers AG (Erlangen, Germany). Cardialysis (Rotterdam, The Netherlands), an expert research organization with almost 40 years of expertise, is responsible for trial services including trials management, as well as Core Laboratory activities.

  • Masdjedi K, van Zandvoort LJC, Balbi MM, et al. Validation of 3-Dimensional Quantitative Coronary Angiography based software to calculate Fractional Flow Reserve: Fast Assessment of STenosis severity (FAST)-study. EuroIntervention. 2019.
  • Neleman T, Masdjedi K, Van Zandvoort LJC, et al. Extended Validation of Novel 3D Quantitative Coronary Angiography-Based Software to Calculate vFFR: The FAST EXTEND Study. JACC Cardiovasc Imaging. 2021;14(2):504-506.
  • Daemen J. et al. Euro PCR 2021, late breaking clinical trial.