xeltis coronary artery bypass graft (xabg) first in human (fih)

Conditions: Multi Vessel Coronary Artery Disease

Summary: a prospective, single arm, non-randomized fih feasibility study to evaluate the preliminary safety and performance of the xabg technology in patients with multi-vessel atherosclerotic coronary artery disease, scheduled by the local heart team to undergo elective coronary artery bypass (cabg) surgery.


Eligibility criteria:
inclusion criteria: * all gender, 18 years of age or older with a minimum life expectancy of 2 years. * elective multi-vessel atherosclerotic cad patients, selected and accepted by the local heart team and confirmed by the screening committee for cabg surgery. * lima bypass graft to lad coronary artery indicated and feasible. * xabg target vessel(s) with proximal occlusion and/or critical stenosis. and 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 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: * 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. intra-operative exclusion criteria: * 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