Zawał serca: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (25)

1. Patients with left ventricular ejection fraction < 35%.
2. Patients with diffusely diseased coronary arteries suggestive of either poor target quality, or poor vessel runoff.
3. Patients requiring emergency surgery.
4. Patients with cardiogenic shock.
5. Patients with any prior open cardiac surgery such as CABG.
6. Any planned concomitant cardiac surgery, including but not limited to: valve surgery, repair of intracardiac shunt, surgical arrhythmia ablation.
7. History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation.
8. Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days of the CABG procedure.
9. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
10. Patient with uncontrolled diabetes (glycated hemoglobin > 8%).
11. Chronic Kidney Disease (CKD) with Glomerular Filtration Rate (GFR) <45 mL/min/1.73m2 (Category: G3b-G5 according to Kidney Disease: Improving Global Outcomes (KDIGO)).
12. Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) <1.5 L/sec or 45% predicted FEV1.
13. Patient with known interstitial lung disease, diagnosed by imaging or pulmonary function tests, including Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO).
14. Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety.
15. Patient on preoperative anticoagulant, or pre existing indication for anticoagulation (e.g. atrial fibrillation, history of thromboembolism), or with known coagulation disorder.
16. Abnormal blood values (e.g. leukopenia, anemia, thrombocytopenia, or thrombocytosis with Platelet Count >400,000 per mL that could influence graft hemostasis or patient recovery
17. Known allergies to study device components: Nitinol, Nickel, Titanium, or agents/medication such as contrast agents, antiplatelet therapy, beta-blocker, or statins required for study assessment or optimal post-CABG medical treatment (hospital standard of care).
18. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet (clopidogrel, ticagrelor, prasugrel) and factor Xa inhibitor therapy.
19. Any planned medical intervention or condition within the 12 months following ATEV implantation that requires temporary or permanent discontinuation of antiplatelet or anticoagulant therapy.
20. History of heparin-induced thrombocytopenia.
21. Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
22. Immunodeficiency including Human Immunodeficiency Virus (HIV), active autoimmune disease, or on immunosuppressant therapy.
23. Treatment with any investigational drug or device within 60 days prior to study entry or ongoing participation in another clinical study of an investigational product.
24. Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.
25. Has any other condition, in the opinion of the principal investigator, which would put the patient at increased risk from participating in the study or otherwise prevent participation.