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

This is an interventional treatment trial for Multi Vessel Coronary Artery Disease Read More

Inclusion Criteria:

• All gender, 19 years of age or older with a minimum life expectancy of 2 years
• Elective patient, selected and accepted by the local Heart Team and confirmed by the Screening Committee for an on-pump full sternotomy CABG surgery
• IMA conduit indicated and feasible for the LAD, SVG CABG indicated and feasible for the circumflex artery (LCX) and right coronary artery (RCA) territories
• Native coronary vessels with proximal occlusion and/or critical stenosis. XABG target vessel with a diameter of ≥ 2 mm and sufficient distal run-off (thrombolysis in myocardial infarction risk (TIMI)-Score ≥ 2).
• Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent
• Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up CT/MRI scan and coronary angiogram
• Patient is suitable for percutaneous coronary intervention (PCI) procedures in case of required emergent procedures at discretion of the local Heart Team

Exclusion Criteria:

• Any previous open-heart surgery or surgical/transcatheter procedure resulting in complex CABG surgery and/or suboptimal cardiovascular imaging of the chest
• History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation
• Concomitant cardiac surgery (e.g. valve treatment, ablation)
• No or insufficient intrathoracic arteries and/or saphenous veins available to undergo full CABG procedure (i.e. treat all target vessels)
• 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.
• Condition requiring immunosuppressive therapy or any chronic inflammatory/autoimmune disease or medication that likely interferes with restorative therapies
• 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 of 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

Intra-operative exclusion criteria:

• Severe calcified aorta (porcelain aorta) or diseased aorta that precludes proximal vein graft anastomoses
• No or insufficient intrathoracic artery and/or saphenous veins available to undergo full CABG procedure (i.e. treat all target vessels).
• Unsuccessful IMA 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 XABG and/or SVG anastomoses.
• Smaller distal coronary artery and/or poor distal run-off as initially expected based on the coronary angiogram.
• Hemodynamic instability before XABG attempt