Pie Medical Imaging (PMI) has launched a new clinical trial to test whether its angiography-based vessel fractional flow reserve (CAAS vFFR) software for guided coronary revascularization is better than conventional FFR-guided revascularization.
The latest trial is led by cardiologist Dr. Joost Daemen of the Erasmus University Medical Center in Rotterdam, the Netherlands.
CAAS vFFR is an angiographic method used to assess coronary physiology and calculate FFR values. The vFFR value indicates the significance of specific coronary lesions and shows where blood flow is limited. The software provides a 3D reconstruction that allows the severity and percentage of stenosis to be assessed, PMI said.
The FAST III study aims to demonstrate noninferiority of CAAS vFFR-guided revascularization compared to a conventional wire-based FFR-guided revascularization approach in patients with either stable coronary syndrome or non-ST segment elevation myocardial infarction and intermediate coronary artery lesions.
The CAAS vFFR approach calculates pressure drop and vFFR value using angiography images only. Its diagnostic accuracy appears promising, as assessed previously in FAST I, FAST Extend, and FAST II studies, PMI said.