Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass

Prior treatment

• Patients requiring emergency surgery.
• Patients with any prior open cardiac surgery such as CABG.
• Any planned concomitant cardiac surgery, including but not limited to: valve surgery, repair of intracardiac shunt, surgical arrhythmia ablation.
• Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
• 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.

Other illness

• History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation.
• Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days of the CABG procedure.
• Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) \<1.5 L/sec or 45% predicted FEV1.
• Patient with known interstitial lung disease, diagnosed by imaging or pulmonary function tests, including Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO).
• Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety.
• Patient on preoperative anticoagulant, or pre existing indication for anticoagulation (e.g. atrial fibrillation, history of thromboembolism), or with known coagulation disorder.
• 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).
• Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet (clopidogrel, ticagrelor, prasugrel) and factor Xa inhibitor therapy.
• Any planned medical intervention or condition within the 12 months following ATEV implantation that requires temporary or permanent discontinuation of antiplatelet or anticoagulant therapy.
• History of heparin-induced thrombocytopenia.
• Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
• Immunodeficiency including Human Immunodeficiency Virus (HIV), active autoimmune disease, or on immunosuppressant therapy.
• 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.

Lab values

• Patients with left ventricular ejection fraction \< 35%.
• Patient with uncontrolled diabetes (glycated hemoglobin \> 8%).
• 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)).
• 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

Other

• Patients with diffusely diseased coronary arteries suggestive of either poor target quality, or poor vessel runoff.
• Patients with cardiogenic shock.
• Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.

• Subjects must meet ALL of the following inclusion criteria:
• Patient with limited quantity of good quality saphenous vein graft (SVG) for planned operation per the surgeon discretion.
• Bypass to at least two coronary arteries (CA); primary target shall be an Internal mammary artery (IMA) bypass to the Left anterior descending (LAD) artery, and one IMD to a secondary target CA that:
  • requires ≤ 15cm long conduit
  • has a diameter at least 1.5 mm at targeted landing site
  • has at least 70% stenosis proximal to the target bypass
  • evidence that sufficient runoff will exist in the target vessel after bypass
• Male or female patients between the ages of 45 and 75 years inclusive.
• Elective patient, selected and accepted by the local Heart Team and confirmed by the Sponsor's Screening Committee for an on-pump full sternotomy coronary artery bypass grafting (CABG) surgery.
• Female subjects must be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening).
• 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 cardiac ultrasound and coronary angiogram or computed tomography (CT).
• Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the ATEV).