The goal of this study is to assess safety and efficacy of Humacyte's coronary tissue engineered vessel (CTEV) used as a bypass conduit in patients requiring multi vessel coronary artery bypass grafting (CABG).
The main question it aims to answer whether the CTEV is feasible as a conduit in CABG surgery.
Each participant will be implanted with a CTEV using standard surgical techniques and followed for up to 36 months for routine assessments, including imaging, physical and clinical examinations, vital signs, laboratory assessments, and safety assessments.
Age ≥18 years with the ability to provide written informed consent.
Planned first isolated CABG surgery for atherosclerotic coronary artery disease with a planned LIMA graft to the LAD and at least one other planned vessel bypass.
Target vessel stenosis of ≥80% (including total occlusion) or a fraction flow reserve (FFR) of ≤0.8.
Good target vessel quality with a diameter of at least 2.5 mm.
Recent (within 7 days) acute myocardial infarction.
Hemodynamic instability or need for emergent CABG surgery.
Acute heart failure or abnormal left ventricular wall motion (e.g., ejection fraction <55%).
Ascending aortic pathology, including aneurysm, dissection, or significant calcification.