INSIGHTFUL-FFR Clinical Trial

Inclusion Criteria:

1. The subject must be at least 18 years of age and younger than 85 years old.

2. Eligible for elective PCI.

3. Stable angina or ACS (non-culprit vessels only and outside of primary interventionduring acute STEMI)

4. Subject willing to participate and able to understand, read and sign the InformedConsent.

Exclusion Criteria:

1. STEMI as clinical presentation.

2. Chronic total occlusion as a target vessel.

3. Significant contraindication to adenosine administration (e.g. heart block, severeasthma)

4. Uncontrolled or recurrent ventricular tachycardia.

5. Hemodynamic instability.

6. Severe valvular disease.

7. Severe renal dysfunction defined as an eGFR ≤30 mL/min/1.73 m2.

8. Comorbidity with life expectancy ≤ 2 years.

9. Inability to take DAPT (both aspirin and a P2Y12 inhibitor) for at least 12 monthsin the patient presenting with an ACS, or at least six months in the patientpresenting with stable CAD, unless the patient is also taking chronic oralanticoagulation in which case a shorter duration of DAPT may be prescribed per localstandard of care.

10. Planned major cardiac or non-cardiac surgery within 24 months after the indexprocedure. Note: major surgery is any invasive procedure in which an extensiveresection is performed, e.g., a body cavity is entered, organs are removed, ornormal anatomy is altered. Note: minor surgery is an operation on the superficialstructures of the body or a manipulative procedure that does not involve a seriousrisk. Planned minor surgery is not excluded.

11. Subject has known hypersensitivity or contraindication to any of the study drugs (including all P2Y12 inhibitors, one or more components of the study devices,including everolimus, zotarolimus, biolimus, sirolimus, cobalt, chromium, nickel,platinum, tungsten, acrylic, and fluoropolymers, or radiocontrast dye that cannot beadequately pre- medicated.

12. The subject has received a functioning solid organ transplant or is active on awaiting list for any solid organ transplants with expected transplantation within 24months.

13. The subject receives immunosuppressant therapy or has known immunosuppressive orsevere autoimmune disease that requires chronic immunosuppressive therapy (e.g.,human immunodeficiency virus, systemic lupus erythematosus, etc.). Note:corticosteroids are not included as immunosuppressant therapy.

14. The subject has previously received or is scheduled to receive radiotherapy to acoronary artery (vascular brachytherapy) or the chest/mediastinum.

15. Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.

16. The subject has a documented or suspected hepatic disorder defined as cirrhosis orChild-Pugh ≥ Class B.

17. The subject has a history of bleeding diathesis or coagulopathy or has had asignificant gastro-intestinal or significant urinary bleed within the past sixmonths. The subject has had a cerebrovascular accident or transient ischemicneurological attack (TIA) within the past six months, any prior intracranial bleed,any permanent neurologic defect, or any known intracranial pathology (e.g.,aneurysm, arteriovenous malformation, etc. The subject has a life expectancy of <2years for any non-cardiac cause.

18. The subject is currently participating in another investigational drug or deviceclinical study.

19. Pregnancy or nursing.

20. Presence of other anatomic or comorbid conditions or other medical, social, orpsychological conditions that, in the investigator's opinion, could limit thesubject's ability to participate in the clinical investigation or to comply withfollow-up requirements or impact the scientific soundness of the clinicalinvestigation results.