Zawał serca: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (25)

1. 1. STEMI within 30 days
2. 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. 3. Prior CABG anytime
4. 4. Silent ischemia only (i.e. no cardiac symptoms related to coronary artery disease) within the prior 4 weeks
5. 5. Documented prior iFR pullback performed in any coronary artery including during the qualifying diagnostic angiogram
6. 6. Any vessel with in-stent restenosis (ISR) requiring treatment
7. 7. Cardiogenic shock defined as systolic blood pressure <90 mmHg for >20 minutes not responding to fluid resuscitation, or need for inotropic, pressor, or device-based hemodynamic support
8. 8. Presence of unstable ventricular arrhythmias
9. 9. Heart rate > 110, including uncontrolled atrial fibrillation (AF)
10. 10. Decompensated congestive heart failure (NYHA Class IV or Killip Class III or IV)
11. 11. 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)
12. 12. Coronary anatomy not amenable to pressure wire manipulation due to extreme tortuosity or complexity such that it is unlikely that a pressure wire could be passed to the distal third of the three major epicardial coronary arteries
13. 13. Any angiographic giant thrombus (i.e., thrombus length > 3x RVD at lesion)
14. 14. Any target vessel with < TIMI III flow
15. 15. Any target lesion with a reference vessel diameter (RVD) less than 2.25mm except for within the side branch of a bifurcation lesion
16. 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 with PCI (other than a CTO supplying non-viable myocardium - see exclusion #11)
17. 17. Known severe aortic or mitral valve stenosis/insufficiency
18. 18. Known non-cardiovascular comorbidity resulting in lifespan <24 months
19. 19. Known left ventricular ejection fraction ≤30%
20. 20. Estimated creatinine clearance (MDRD formula) <30 mL/min/1.73m2 or on dialysis
21. 21. Any cardiac or non-cardiac surgical procedure planned within 12 months after enrollment, or any procedure planned within 6 months after enrollment that would necessitate discontinuation of dual antiplatelet therapy
22. 22. Known pregnancy or planning to become pregnant (women of child-bearing potential must have a negative pregnancy test within 1 week of enrollment)
23. 23. Participating in another investigational drug or device study that has not reached its primary endpoint
24. 24. Any condition such as dementia or substance abuse that may impair the patient's ability to comply with all study procedures, including medication compliance and follow-up visits
25. 25. Patient is a member of a vulnerable population who, in the judgment of the investigator, is unable to give Informed Consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy. This may include 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 hospital and laboratory personnel, employees of the Sponsor, members of the armed forces, and persons kept in detention.