Zawał serca: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (24)

1. Total arterial bypass grafting indicated and feasible
2. Any previous open-heart surgery or surgical/transcatheter procedure that could compromise imaging follow up.
3. History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation
4. Concomitant cardiac surgery (e.g. valve treatment, ablation).
5. Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days prior to the CABG procedure
6. Left ventricular ejection fraction ≤ 35%.
7. Severe kidney disease, renal dysfunction (Cr> 2.0mg/dL) or Glomerular Filtration Rate (GFR) < 50mL/min or active dialysis patients.
8. Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) <1.5 lit/sec.
9. Endocarditis, pericarditis or any other active systemic infection that would interfere with subject safety.
10. Active bleeding disorder and/or any coagulopathy or thromboembolic disease or other indication requiring anticoagulation
11. Known Heparin Induced Thrombocytopenia (HIT)
12. Abnormal blood values (e.g. leukopenia, anemia or thrombocytopenia) that could influence graft hemostasis or patient recovery.
13. Use of immunosuppressive therapy or medication or active clinically inflammatory/autoimmune disease or immunodeficiency that likely interferes with restorative therapies
14. Known and non-treatable allergies to study device (Nitinol) or agents/medication, such as contrast agents, antiplatelet therapy, beta-blocker, statins required for study assessment or optimal post-CABG medical treatment (hospital SOC).
15. Need for emergency surgery for any reason and/or intervention/surgery prior to and within 12 months after the CABG surgery that requires antiplatelet therapy discontinuation.
16. Currently in investigational device or drug study or participated in the last 30 days.
17. Pregnancy or females currently lactating or childbearing potential who are sexually active and are not willing to use adequate contraceptive precautions for the next 2 years.
18. Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
19. 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. Intra-operative Exclusion Criteria:
20. Severe calcified aorta (porcelain aorta) or diseased aorta that precludes proximal vein graft anastomoses
21. Unsuccessful LIMA to LAD anastomosis
22. After chest opening and visual inspection identification of active pericarditis/endocarditis and/or diffuse calcification in target vessels and/or any other reason precluding sufficient distal anastomoses.
23. Smaller distal coronary artery and/or poor distal run-off and/or XABG patient/device size mismatch as initially expected in the pre-operative workup.
24. Hemodynamic instability before XABG attempt