Radiographic Imaging Validation and EvALuation for Angio iFR (ReVEAL iFR)

Inclusion Criteria:

1. ≥18 years old
2. At least 1 de-novo lesion in 1 or more major epicardial vessels of 40-90% angiographicstenosis with a reference vessel size ≥2.5mm in the diseased segment by visualestimate
3. Able and willing to provide informed consent

Exclusion Criteria:

1. Presenting with an acute coronary syndrome (ACS), or documented ACS within 4 weeksprior to the scheduled index procedure
2. Cardiogenic shock (sustained (>10 min) systolic blood pressure <90 mmHg in absence ofinotropic support or the presence of an intra-aortic balloon pump)
3. Presence of cardiac arrhythmias (e.g., atrial fibrillation, AV-block)
4. Prior cardiac surgery or implant, including CABG, heart transplant, surgical heartvalve replacement or repair, TAVI/TAVR, presence of an ICD or pacemaker
5. Target vessel supplied by a left main coronary artery demonstrating any diseasepresent (isolated or non-isolated)
6. Target vessel supplied by right coronary artery demonstrating any ostial disease (located immediately at the origin of the coronary vessels from the aorta)
7. Target vessel with Chronic Total Occlusion (CTO) in the ipsilateral territory ortarget vessel with an untreated CTO in the contralateral territory. Note: if a CTOexisting in the contralateral territory is successfully opened, the target vessel inthe contralateral territory can be included following CTO treatment.
8. Target vessel with severe tortuosity (≥1 bends of 90° or more, or ≥3 or more bends of 45°- 90° proximal to the diseased segment)
9. Target vessel with heavy calcification (multiple persisting opacifications of thecoronary wall visible in more than one projection surrounding the complete lumen ofthe coronary artery at the site of the lesion.)
10. Target vessel with TIMI flow grade 1 or 0
11. Target vessel with severe diffuse disease (more than 75% of the length of the segmenthaving a vessel diameter of 2mm, irrespective of the presence or absence of a lesion)
12. Target lesion is at a bifurcation/trifurcation
13. Target arteries supplying akinetic or severely hypokinetic territories if alreadyknown based on prior imaging
14. Target vessel is supplied by major collaterals
15. Target stenosis associated with myocardial bridge
16. Any vascular abnormality precluding optimal contrast opacification (e,g, thrombus,ulceration)
17. Severe aortic or mitral valve disease
18. Known ejection fraction ≤30%
19. Known severe renal insufficiency (eGFR<30ml/min/1.72m2)
20. Any fluoroscopic interference that renders the wire position unclear
21. Contraindication for adenosine or other hyperemic agent (e.g., caffeine ingestion ≤18hours, COPD, hypotension, AV block)
22. Known pregnancy or planning to become pregnant
23. Participating in another interventional investigational study