Philips Clinical & Medical Affairs Global
Multi-center, prospective, randomized controlled study comparing PCI guided by angiography versus iFR Co-Registration using commercially available Philips pressure guidewires and the SyncVision co-registration system, employing an adaptive design study for interim sample size re-estimation.
DEFINE GPS Substudy: Characterization of Intermediate Lesions (ChIL) will enroll approximately 350 patients at up to 20 sites. This multi-center, prospective, registry will enroll patients consented to be randomized into the DEFINE GPS study but ultimately screen fail. Baseline patient medical and demographic data will be collected along with angiographic and functional data from vessels with intermediate disease deferred from revascularization and will be used to establish a body of imaging data that can be used to validate new image-based physiology applications.
Inclusion Criteria: * 1\. Adult men and women (local age of consent) who present with stable or unstable angina, or NSTEMI. * 2\. Undergoing cardiac catheterization with planned PCI or possible ad hoc PCI * 3\. Following angiography, PCI is indicated in at least one coronary artery\* on the basis of one or more of the following: 1. Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac enzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%; 2. One or more angiographic stenoses present with ≥80% stenosis severity by visual estimation; 3. One or more angiog…
Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy