Coronary Artery DiseasePhase 2NCT07730528
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)
A Phase 2 study testing Humacyte Coronary Tissue Engineered Vessel (CTEV) in people with Coronary Artery Disease, run by Humacyte, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Humacyte Coronary Tissue Engineered Vessel (CTEV)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Sep 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- 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:
- 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)
- Participants who are considered not suitable for on-pump CABG procedure.
About this study
Official title: A Phase 2a Study for the Evaluation of Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) as a Vascular Conduit for Coronary Artery Bypass Grafting in Patients With Coronary Artery Disease
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.
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Humacyte Coronary Tissue Engineered Vessel (CTEV)
- Keywords
- Coronary Artery Bypass Grafting, CTEV, Tissue Engineered Vessel, CABG
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 group | Role | What they receive |
|---|---|---|
| Humacyte Coronary Tissue Engineered Vessel (CTEV) | Experimental | Surgically implanted CTEV for CABG Receives: Biological: Humacyte Coronary Tissue Engineered Vessel (CTEV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV
Measured: 36 months
Secondary outcomes (5)
Graft patency at month 2 assessment among all implanted grafts
Measured: 2 Months
Graft patency at month 6 assessments among all implanted grafts
Measured: 6 months
Graft patency at month 12 assessments among all implanted grafts
Measured: 12 Months
Graft patency at month 24 assessments among all implanted grafts
Measured: 24 Months
Graft patency at month 36 assessments among all implanted grafts
Measured: 36 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Humacyte, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730528
- Sponsor's protocol ID
- CLN-PRO-V021
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a Study for the Evaluation of Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) as a Vascular Conduit for Coronary Artery Bypass Grafting in Patients With Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT07730528
- Acronym / sponsor ID
- CLN-PRO-V021
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Grafting, CTEV, Tissue Engineered Vessel, CABG
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Humacyte, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Humacyte Coronary Tissue Engineered Vessel (CTEV) | Experimental | Biological: Humacyte Coronary Tissue Engineered Vessel (CTEV)Surgically implanted CTEV for CABG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Humacyte 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. | Biological | Humacyte Coronary Tissue Engineered Vessel (CTEV) |
Primary outcome
Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV
Time frame: 36 months
5 secondary outcomes
Graft patency at month 2 assessment among all implanted grafts
Time frame: 2 Months
Graft patency at month 6 assessments among all implanted grafts
Time frame: 6 months
Graft patency at month 12 assessments among all implanted grafts
Time frame: 12 Months
Graft patency at month 24 assessments among all implanted grafts
Time frame: 24 Months
Graft patency at month 36 assessments among all implanted grafts
Time frame: 36 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Humacyte Coronary Tissue Engineered Vessel (CTEV) in people with Coronary Artery Disease, run by Humacyte, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of events (MACE, AE, AESI, etc.) in all participants implanted with CTEV (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.