Pie Medical Imaging has announced the enrolment of the 500th patient in the FAST III clinical trial, investigating the use of angiography-based vessel fractional flow reserve (CAAS vFFR) in patients undergoing coronary revascularisation procedures.
In this trial, a CAAS vFFR guided strategy is compared to a fractional flow reserve (FFR)-guided strategy to guide coronary revascularisation. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularisation at one year post-randomisation.
The trial, led by Joost Daemen (Thoraxcenter at the Erasmus University Medical Center, Rotterdam, The Netherlands), is an investigator initiated international, multicentre randomised, non-inferiority trial. Five hundred patients are enrolled by hospitals with expertise in coronary physiology at 25 sites across Europe in The Netherlands, Germany, Spain, Ireland, UK, Italy, and France. A total of 35 sites will be recruited with the final aim to include 2,228 patients by the end of the year.
CAAS vFFR is an angio-based FFR software suite to enable physiological assessment of intermediate coronary stenosis without the need of a pressure wire and adenosine. The vFFR value can be calculated with solely two angiographic projections and the aortic root pressure. This vFFR has a high correlation and diagnostic accuracy compared with wire based invasive FFR and NHPR measurements and the vFFR results are proven to be highly reproducible.
“The FAST III trial, together with several other studies currently being performed with CAAS vFFR, will increase the scientific body of evidence showing that the CAAS vFFR software is an excellent alternative to invasive wire-based physiological measurements” said Rene Guillaume, Managing Director of Pie Medical Imaging.
The trial is funded by research grants from Pie Medical Imaging (Maastricht, the Netherlands) and Siemens Healthineers (Erlangen, Germany). The study is sponsored by ECRI (European Cardiovascular Research Institute, Rotterdam-the Netherlands). Cardialysis (Rotterdam, The Netherlands) is responsible for trial services including trials management and Core Laboratory activities.