Pie Medical Imaging’s Caas vFFR for PCI Guidance Is Evaluated in Ongoing FAST III RCT

January 20, 2023—Pie Medical Imaging (PMI), a global cardiac imaging company based in the Netherlands, announced that the 500th patient has been enrolled in the multicenter FAST III randomized clinical trial. The investigator-initiated trial is led by Joost Daemen, MD, cardiologist at the Thoraxcenter at the Erasmus University Medical Center in Rotterdam, the Netherlands.

According to PMI, the FAST III trial is investigating the use of the company’s cardiovascular angiographic analysis system (Caas) for angiography-based vessel fractional flow reserve (Caas vFFR) in patients undergoing coronary revascularization procedures compared to an FFR-guided strategy. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at 1-year post randomization.

The company advised that the first 500 patients in the international noninferiority trial were enrolled at 25 hospitals with expertise in coronary physiology in the Netherlands, Germany, Spain, Ireland, the United Kingdom, Italy, and France. A total of 35 sites will be recruited with the final aim of including 2,228 patients by the end of 2023.

PMI’s Caas vFFR software suite is intended to enable the physiologic assessment of intermediate coronary stenosis without the need for a pressure wire and adenosine. The vFFR value can be calculated with two angiographic projections and the aortic root pressure.

The company stated that this vFFR has a high correlation and diagnostic accuracy compared with wire-based invasive FFR and NHPR—nonhyperemic pressure ratio measurements. Additionally, the vFFR results are proven to be highly reproducible.

The investigator-initiated FAST III trial is funded by research grants from Pie Medical Imaging and Siemens Healthineers. The study is sponsored by ECRI, the European Cardiovascular Research Institute in Rotterdam, the Netherlands.