Philips to begin DEFINE GPS global trial for PCI procedures

Royal Philips has will begin a new randomized controlled study to evaluate patient outcomes of percutaneous coronary intervention (PCI) guided by integrated instant wave-Free Ratio (iFR) and interventional X-ray images. PCI is one of the main treatment options to open narrowed coronary arteries of the heart in patients with coronary artery disease. European and US guidelines already endorse the use of coronary physiologic measurements with iFR and Fractional Flow Reserve (FFR) for diagnostic purposes to determine the significance of a narrowed coronary artery. The DEFINE GPS (Distal Evaluation of Functional performance with Intravascular sensors to assess the Narrowing Effect: Guided Physiologic Stenting) study will be the first time that the use of iFR in conjunction with the Philips Image-Guided Co-registration System (SyncVision) is evaluated for PCI guidance and the optimization of treatment outcomes.
The global multicentre, prospective, randomized controlled DEFINE GPS study will investigate the impact of iFR Co-registration on both outcomes and cost effectiveness. The primary endpoint is target vessel failure (a composite of cardiac death, target vessel Myocardial Infarction and ischemia-driven target vessel revascularization) or re-hospitalization for progressive or unstable ischemia at two years.
The DEFINE GPS study is sponsored by Philips with the Cardiovascular Research Foundation overseeing core lab and clinical event committee activities. The first patients will be recruited in the second half of 2020.