Distal Evaluation of Functional Performance with Intravascular Sensors to Assess the Narrowing Effect: Guided Physiologic Stenting

Inclusion Criteria:

1. Adult men and women (local age of consent) who present with stable or unstableangina, 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 thebasis of one or more of the following:

4. Presenting with NSTE-ACS (unstable angina with ECG changes or cardiacenzyme-positive NSTEMI) with an identified culprit lesion with DS ≥50%;

5. One or more angiographic stenoses present with ≥80% stenosis severity by visualestimation;

6. One or more angiographic stenoses present with ≥50% to <80% stenosis severityby visual estimation and an abnormal non-invasive stress test in thedistribution of the lesion(s) within the past 60 days;

7. One or more angiographic stenoses are present with ≥50% to <80% stenosisseverity by visual estimation and a spot iFR measure ≤0.89 or FFR≤0.80 forborderline iFR..

• 4 Subject is willing to comply with all scheduled visits and tests and has providedinformed written consent

Exclusion Criteria:

1. STEMI within 30 days

2. PCI within the prior 12 months, or any PCI planned after the study procedure (other than planned staged procedures of randomized vessels which are allowed)

3. Prior CABG anytime

4. Silent ischemia only (i.e. no cardiac symptoms related to coronary arterydisease) within the prior 4 weeks

5. Documented prior iFR pullback performed in any coronary artery including duringthe qualifying diagnostic angiogram

6. Any vessel with in-stent restenosis (ISR) requiring treatment

7. Cardiogenic shock defined as systolic blood pressure <90 mmHg for >20 minutesnot responding to fluid resuscitation, or need for inotropic, pressor, ordevice-based hemodynamic support

8. Presence of unstable ventricular arrhythmias

9. Heart rate > 110, including uncontrolled atrial fibrillation (AF)

10. Decompensated congestive heart failure (NYHA Class IV or Killip Class III orIV)

11. Chronic total occlusion (CTO) of a target vessel (exception: a CTO may bepresent in a non-target vessel if it is supplying non-viable myocardium andthere is no intent to open the CTO during the index or later procedure)

12. Coronary anatomy not amenable to pressure wire manipulation due to extremetortuosity or complexity such that it is unlikely that a pressure wire could bepassed to the distal third of the three major epicardial coronary arteries

13. Any angiographic giant thrombus (i.e., thrombus length > 3x RVD at lesion)

14. Any target vessel with < TIMI III flow

15. Any target lesion with a reference vessel diameter (RVD) less than 2.25mmexcept for within the side branch of a bifurcation lesion

16. 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 withPCI (other than a CTO supplying non-viable myocardium - see exclusion #11)

17. Known severe aortic or mitral valve stenosis/insufficiency

18. Known non-cardiovascular comorbidity resulting in lifespan <24 months

19. Known left ventricular ejection fraction ≤30%

20. Estimated creatinine clearance (MDRD formula) <30 mL/min/1.73m2 or on dialysis

21. Any cardiac or non-cardiac surgical procedure planned within 12 months afterenrollment, or any procedure planned within 6 months after enrollment thatwould necessitate discontinuation of dual antiplatelet therapy

22. Known pregnancy or planning to become pregnant (women of child-bearingpotential must have a negative pregnancy test within 1 week of enrollment)

23. Participating in another investigational drug or device study that has notreached its primary endpoint

24. Any condition such as dementia or substance abuse that may impair the patient'sability to comply with all study procedures, including medication complianceand follow-up visits

25. Patient is a member of a vulnerable population who, in the judgment of theinvestigator, is unable to give Informed Consent for reasons of incapacity,immaturity, adverse personal circumstances or lack of autonomy. This mayinclude individuals with mental disability, persons in nursing homes, children,impoverished persons, persons in emergency situations, homeless persons,nomads, refugees, and those permanently incapable of giving informed consent.Vulnerable populations also include university students, subordinate hospitaland laboratory personnel, employees of the Sponsor, members of the armedforces, and persons kept in detention.