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.
Inclusion Criteria:
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.
An RCA or LCx territory target vessel for the CTEV graft with the following characteristics:
Exclusion Criteria:
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.
Prior cardiac surgery.
Planned concomitant valve or aortic surgery.
Known bleeding disorder or thrombophilia.
Required post-operative anticoagulation therapy.
Known or suspected allergies or contraindications to aspirin or clopidogrel, heparin, or contrast agents that cannot be adequately pre-treated.
Chronic kidney disease with eGFR < 45 ml/min/1.73 m2).
Previous exposure to the Humacyte ATEV (Symvess).
Use of any investigational drug or device within 60 days.
Women of childbearing potential defined as not sterile or not at least 1 year postmenopausal.
Any condition, including active substance abuse, that in the opinion of the investigator, prevents participants from following the protocol, including the planned CT angiographic follow-up through at least 12-14 months.
Active infection requiring ongoing antibiotic therapy or conditions that would increase the risk of infection or other complications evidenced by the following:
Clinically significant hepatic cirrhosis or dysfunction evident by any of the following laboratory abnormalities:
Participants who are considered not suitable for on-pump CABG procedure.
Surgically implanted CTEV for CABG
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