Coronary Artery Disease
Conditions
Keywords
Coronary Artery Bypass Grafting, CTEV, Tissue Engineered Vessel, CABG
Brief summary
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.
Detailed description
Prospective, non-randomized, open-label clinical study to assess the safety and efficacy of coronary tissue engineered vessel (CTEV) for secondary coronary targets in patients needing multiple coronary artery bypass. Each eligible patient will have the left anterior descending (LAD) CA bypassed using the left internal mammary artery (LIMA). A single CTEV (single proximal and distal anastomoses) will be used to bypass either second or third coronary arteries (CA) bypass target. A native vessel shall be used for any additional targets as needed. Patients will be followed at routine visits for up to 3 years post-implant.
Interventions
BIOLOGICALHumacyte Coronary Tissue Engineered Vessel (CTEV)
The 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.
Sponsors
Humacyte, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A sentinel cohort of 3 patients will be enrolled and implanted with CTEV at a single center. Following review of the 2-month safety data for the sentinel cohort, a second cohort of 3 participants followed by a third cohort of 4 participants will be enrolled.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years with the ability to provide written informed consent. 2. 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. 3. An RCA or LCx territory target vessel for the CTEV graft with the following characteristics: 1. Target vessel stenosis of ≥80% (including total occlusion) or a fraction flow reserve (FFR) of ≤0.8. 2. Good target vessel quality with a diameter of at least 2.5 mm. 3. Good target vessel run-off as determined by the Investigator.
Exclusion criteria
1. Recent (within 7 days) acute myocardial infarction. 2. Hemodynamic instability or need for emergent CABG surgery. 3. Acute heart failure or abnormal left ventricular wall motion (e.g., ejection fraction \<55%). 4. Ascending aortic pathology, including aneurysm, dissection, or significant calcification. 5. Prior cardiac surgery. 6. Planned concomitant valve or aortic surgery. 7. Known bleeding disorder or thrombophilia. 1. Thrombocytopenia (platelet count \<100 x 109/L) 2. Clinically significant anemia (hemoglobin \<9.0 g/dL) 3. Elevated prothrombin time (INR \> 1.3) or partial thromboplastin time (\>35 seconds) not due to anticoagulation therapy. 8. Required post-operative anticoagulation therapy. 9. Known or suspected allergies or contraindications to aspirin or clopidogrel, heparin, or contrast agents that cannot be adequately pre-treated. 10. Chronic kidney disease with eGFR \< 45 ml/min/1.73 m2). 11. Previous exposure to the Humacyte ATEV (Symvess). 12. Use of any investigational drug or device within 60 days. 13. Women of childbearing potential defined as not sterile or not at least 1 year postmenopausal. 14. 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. 15. Active infection requiring ongoing antibiotic therapy or conditions that would increase the risk of infection or other complications evidenced by the following: 1. Compromised immune function from medication or underlying disease 2. Clinically significant low white blood cell count (leukopenia) 3. Uncontrolled diabetes mellitus (HbgA1c \>8.0%, serum glucose \>300 mg/dL) 4. Active malignancy. 16. Clinically significant hepatic cirrhosis or dysfunction evident by any of the following laboratory abnormalities: 1. AST or ALT ≥3x ULN 2. low serum albumin \< 2.0 g/dL 3. high bilirubin \> 2 mg/dL) 17. Participants who are considered not suitable for on-pump CABG procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV | 36 months |
Secondary
| Measure | Time frame |
|---|---|
| Graft patency at month 2 assessment among all implanted grafts | 2 Months |
| Graft patency at month 6 assessments among all implanted grafts | 6 months |
| Graft patency at month 12 assessments among all implanted grafts | 12 Months |
| Graft patency at month 24 assessments among all implanted grafts | 24 Months |
| Graft patency at month 36 assessments among all implanted grafts | 36 Months |
Outcome results
None listed