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)

NCT07730528 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CLN-PRO-V021
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Bypass Grafting; CTEV; Tissue Engineered Vessel; CABG

Outcome Measures

Primary Outcomes (1)

• Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV

  36 months

Secondary Outcomes (5)

• 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

Study Arms (1)

Humacyte Coronary Tissue Engineered Vessel (CTEV)

EXPERIMENTAL

Surgically implanted CTEV for CABG

Biological: Humacyte Coronary Tissue Engineered Vessel (CTEV)

Interventions

Humacyte Coronary Tissue Engineered Vessel (CTEV) BIOLOGICAL

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.

Humacyte Coronary Tissue Engineered Vessel (CTEV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.

Sponsors & Collaborators

• Humacyte, Inc.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share