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.
Sequential
Humacyte Coronary Tissue Engineered Vessel (CTEV)
Biological/VaccineThe CTEV is a tissue-engineered acellular vascular conduit regulated as a biological product by the Food and Drug Administration (FDA). The CTEV has an inner diameter of 3.5 mm and with approximately 20 cm of usable length.
Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV
Graft patency at month 2 assessment among all implanted grafts
Graft patency at month 6 assessments among all implanted grafts
Graft patency at month 12 assessments among all implanted grafts
Graft patency at month 24 assessments among all implanted grafts
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This trial is not recruiting at the moment. You can still explore other options:
