Could Lab-Grown arteries replace vein grafts in heart bypass surgery?
NCT ID NCT07730528
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This trial tests whether a lab-grown, tissue-engineered blood vessel can be safely used as a bypass graft in people with coronary artery disease undergoing heart bypass surgery. Ten participants will receive the artificial vessel alongside a standard graft, and researchers will monitor how well it stays open and whether any complications arise over three years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a lab-grown tissue-engineered blood vessel called the Coronary Tissue Engineered Vessel (CTEV)
- What this could lead to
- If successful, this could provide a ready-made, off-the-shelf bypass graft that avoids the need to harvest a vein from the patient's own leg or arm.
- What could go wrong
- This is a very early, small trial with only 10 participants, so results may not apply widely. The graft could fail to stay open or cause blood clots or other complications.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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