Advancing Cath Lab Results With FFRangio Coronary Physiology Assessment

Exclusion Criteria

• •1. Subject with ST-elevation (MI (STEMI) within 72 hours at time of study enrollment
• •2. Prior coronary artery bypass graft (CABG) with patent grafts to the study vessel(s)
• •3. Patients undergoing coronary physiologic assessment where one possible outcome is referral for CABG
• •4. The study vessel supplies a significant nonviable territory (e.g., prior transmural MI)
• •5. Severe left sided valvular heart disease
• •6. Most recent documented LVEF ≤30%
• •7. Women who are pregnant or breastfeeding (women of childbearing potential are required to have negative pregnancy test within 1 week of index procedure)
• •8. Patients with life expectancy \<1 year life as estimated by treating physician.
• •9. Subjects enrolled in other ongoing non-registry clinical studies that would impact conduct or outcomes of this study (registries and long-term follow-up of other studies are allowed)
• •10. Subjects who have undergone angiographic or wire-based coronary physiological assessment for 1 or more potential study lesions within 30 days of enrollment.
• •1. Coronary angiogram is not acquired per instructions as defined in the Study Protocol
• •2. Sthe study lesion is the clear culprit for a NSTEACS
• •3. Angiographic evidence of a procedural complication (e.g., acute stent thrombosis, flow-limiting dissection, perforation, slow/no reflow, or other) prior to randomization
• •4. Thrombolysis in myocardial infarction (TIMI) Grade 2 flow or lower in any study vessel at time of enrollment
• •5. The study vessel is in a left coronary vessel with separate left anterior descending and left circumflex ostia arising from the aorta
• •6. The study lesion involves the left main coronary artery (stenosis ≥ 50%)
• •7. The study lesion is in an ectatic or aneurysmal coronary segment (defined as lumen diameter 1.5x diameter or the reference vessel)