Xeltis Coronary Artery Bypass Graft (XABG) First in Human (FIH)

Exclusion Criteria

• •Total arterial bypass grafting indicated and feasible
• •Any previous open-heart surgery or surgical/transcatheter procedure that could compromise imaging follow up.
• •History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation
• •Concomitant cardiac surgery (e.g. valve treatment, ablation).
• •Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days prior to the CABG procedure
• •Left ventricular ejection fraction ≤ 35%.
• •Severe kidney disease, renal dysfunction (Cr\> 2.0mg/dL) or Glomerular Filtration Rate (GFR) \< 50mL/min or active dialysis patients.
• •Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) \<1.5 lit/sec.
• •Endocarditis, pericarditis or any other active systemic infection that would interfere with subject safety.
• •Active bleeding disorder and/or any coagulopathy or thromboembolic disease or other indication requiring anticoagulation
• •Known Heparin Induced Thrombocytopenia (HIT)
• •Abnormal blood values (e.g. leukopenia, anemia or thrombocytopenia) that could influence graft hemostasis or patient recovery.
• •Use of immunosuppressive therapy or medication or active clinically inflammatory/autoimmune disease or immunodeficiency that likely interferes with restorative therapies
• •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).
• •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.
• •Currently in investigational device or drug study or participated in the last 30 days.
• •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.
• •Subject has medical, social or psychosocial factors that, in the opinion of the Investigator, could impact safety or compliance.
• •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.
• •Severe calcified aorta (porcelain aorta) or diseased aorta that precludes proximal vein graft anastomoses
• •Unsuccessful LIMA to LAD anastomosis
• •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.
• •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.
• •Hemodynamic instability before XABG attempt