Study to Evaluate the Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) in Patients With Coronary Artery Disease Requiring Coronary Artery Bypass Grafting (CABG)

Korábbi kezelés

• Hemodynamic instability or need for emergent CABG surgery.
• Prior cardiac surgery.
• Planned concomitant valve or aortic surgery.
• 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.
• Previous exposure to the Humacyte ATEV (Symvess).
• Use of any investigational drug or device within 60 days.

Más betegség

• Recent (within 7 days) acute myocardial infarction.
• 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.

Laborértékek

• Acute heart failure or abnormal left ventricular wall motion (e.g., ejection fraction <55%).
• Known bleeding disorder or thrombophilia.
  • Thrombocytopenia (platelet count <100 x 109/L)
  • Clinically significant anemia (hemoglobin <9.0 g/dL)
  • Elevated prothrombin time (INR > 1.3) or partial thromboplastin time (>35 seconds) not due to anticoagulation therapy.
• Chronic kidney disease with eGFR < 45 ml/min/1.73 m2).
• Active infection requiring ongoing antibiotic therapy or conditions that would increase the risk of infection or other complications evidenced by the following:
  • Compromised immune function from medication or underlying disease
  • Clinically significant low white blood cell count (leukopenia)
  • Uncontrolled diabetes mellitus (HbgA1c >8.0%, serum glucose >300 mg/dL)
  • Active malignancy.
• Clinically significant hepatic cirrhosis or dysfunction evident by any of the following laboratory abnormalities:
  • AST or ALT ≥3x ULN
  • low serum albumin < 2.0 g/dL
  • high bilirubin > 2 mg/dL)

Egyéb

• Ascending aortic pathology, including aneurysm, dissection, or significant calcification.
• Women of childbearing potential defined as not sterile or not at least 1 year postmenopausal.
• Participants who are considered not suitable for on-pump CABG procedure.

• 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:
  • 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.
  • Good target vessel run-off as determined by the Investigator.