Pie Medical Imaging has announced the completion of enrolment in FASTIII, a multicentre randomised clinical trial, investigating the use of angiography-based vessel fractional flow reserve (CAAS vFFR) in patients undergoing coronary revascularisation procedures.
vFFR can assess whether a coronary artery narrowing is functionally significant and may require revascularisation. FASTIII will establish its role in routine clinical practice.
The trial is the largest non-inferiority trial running (having enrolled 2,228 patients), in which an angiographically derived vFFR guided strategy is compared to an FFR-guided strategy to guide coronary revascularisation. The primary endpoint is a composite of all-cause death, any myocardial infarction, or any revascularization at one year post randomisation.
“The FASTIII trial is aimed to establish the role of vFFR to coronary revascularisation in patients with intermediate coronary artery lesions. An important milestone was reached Friday, 31 May, when the last patient was enrolled,” said Joost Daemen (Thoraxcenter at the Erasmus University Medical Center, Rotterdam, The Netherlands), principal investigator of the trial. “The next phase will consist of close follow-up of all patients who generously agreed to participate in the important trial. We hope to present our findings by the end of 2025.”
“Pie Medical Imaging is committed to providing clinicians and patients with long-term coronary data to inform their treatment decisions,” said René Guillaume, managing director at Pie Medical Imaging. “Our prior studies have shown diagnostic accuracy and reproducibility of vFFR calculation.”
The trial is funded by research grants from Pie Medical Imaging and Siemens Healthineers. The study is sponsored by the European Cardiovascular Research Institute (ECRI). Cardialysis is responsible for trial services including trial management and core laboratory activities.
