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)

Sponsor
Humacyte, Inc.
Study ID
NCT07730528
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jul 28, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2030

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Humacyte Coronary Tissue Engineered Vessel (CTEV)
    Surgically implanted CTEV for CABG

Primary Outcome Measure

Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV [ Time Frame: 36 months ]

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