Distal Evaluation of Functional Performance With Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting (DEFINE GPS)

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.

Inclusion Criteria:

1. Adult men and women 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:

• Presenting with NSTE-ACS (unstable angina with ECG changes or cardiac enzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%;
• One or more angiographic stenoses present with ≥80% stenosis severity by visual estimation;
• One or more angiographic stenoses present with ≥50% to <80% stenosis severity by visual estimation and an abnormal non-invasive stress test in the distribution of the lesion(s) within the past 60 days;
• One or more angiographic stenoses are present with ≥50% to <80% stenosis severity by visual estimation and a spot iFR measure ≤0.89 or FFR≤0.80 for borderline iFR..

Exclusion Criteria:

1. STEMI within 30 days
2. PCI within the prior 12 months
3. Prior CABG
4. Any vessel with in-stent restenosis (ISR) requiring treatment
5. Cardiogenic shock
6. Chronic total occlusion (CTO) of a target vessel (exception: a CTO may be present in a non-target vessel if it is supplying non-viable myocardium and there is no intent to open the CTO during the index or later procedure)
7. Any angiographic giant thrombus (i.e., thrombus length > 3x RVD at lesion)
8. Any target vessel with < TIMI III flow
9. Any target lesion with a reference vessel diameter (RVD) less than 2.25mm except for within the side branch of a bifurcation lesion
10. Any non-target lesion with a reference vessel diameter (RVD) greater than 2.00mm that contains an ≥80% stenosis and is not intended for treatment with PCI (other than a CTO supplying non-viable myocardium - see exclusion #11)
11. Known severe aortic or mitral valve stenosis/insufficiency
12. Known left ventricular ejection fraction ≤30%