Engineered blood vessels could transform heart bypass surgery
NCT ID NCT07078370
First seen Jun 27, 2026 · Last updated Jul 30, 2026 · Updated 2 times
Summary
This study tests a new lab-made blood vessel (ATEV) for use in coronary artery bypass surgery in 20 people with multi-vessel heart disease. The goal is to see if it is safe and can be successfully implanted as an alternative to using the patient's own veins. Researchers will monitor for heart-related complications and check if the vessel stays open over 12 months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Jul 2027
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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45 to 75 years
- 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: Subjects must meet ALL of the following inclusion criteria: 1. Patient with limited quantity of good quality saphenous vein graft (SVG) for planned operation per the surgeon discretion. 2. Bypass to at least two coronary arteries (CA); primary target shall be an Internal mammary artery (IMA) bypass to the Left anterior descending (LAD) artery, and one IMD to a secondary target CA that: * requires ≤ 15cm long conduit * has a diameter at least 1.5 mm at targeted landing site * has at least 70% stenosis proximal to the target bypass * evidence that sufficient runoff will exist in the target vessel after bypass 3. Male or female patients between the ages of 45 and 75 years inclusive. 4. Elective patient, selected and accepted by the local Heart Team and confirmed by the Sponsor's Screening Committee for an on-pump full sternotomy coronary artery bypass grafting (CABG) surgery. 5. Female subjects must be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening). 6. Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent. 7. Patient has been informed and agrees to pre- and post-procedure follow-up, including follow-up cardiac ultrasound and coronary angiogram or computed tomography (CT). 8. Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the ATEV). Exclusion Criteria: 1. Patients with left ventricular ejection fraction \< 35%. 2. Patients with diffusely diseased coronary arteries suggestive of either poor target quality, or poor vessel runoff. 3. Patients requiring emergency surgery. 4. Patients with cardiogenic shock. 5. Patients with any prior open cardiac surgery such as CABG. 6. Any planned concomitant cardiac surgery, including but not limited to: valve surgery, repair of intracardiac shunt, surgical arrhythmia ablation. 7. History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation. 8. Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days of the CABG procedure. 9. Concomitant life-threatening disease likely to limit life expectancy to less than 2 years. 10. Patient with uncontrolled diabetes (glycated hemoglobin \> 8%). 11. Chronic Kidney Disease (CKD) with Glomerular Filtration Rate (GFR) \<45 mL/min/1.73m2 (Category: G3b-G5 according to Kidney Disease: Improving Global Outcomes (KDIGO)). 12. Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) \<1.5 L/sec or 45% predicted FEV1. 13. Patient with known interstitial lung disease, diagnosed by imaging or pulmonary function tests, including Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO). 14. Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety. 15. Patient on preoperative anticoagulant, or pre existing indication for anticoagulation (e.g. atrial fibrillation, history of thromboembolism), or with known coagulation disorder. 16. Abnormal blood values (e.g. leukopenia, anemia, thrombocytopenia, or thrombocytosis with Platelet Count \>400,000 per mL that could influence graft hemostasis or patient recovery 17. Known allergies to study device components: Nitinol, Nickel, Titanium, or agents/medication such as contrast agents, antiplatelet therapy, beta-blocker, or statins required for study assessment or optimal post-CABG medical treatment (hospital standard of care). 18. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet (clopidogrel, ticagrelor, prasugrel) and factor Xa inhibitor therapy. 19. Any planned medical intervention or condition within the 12 months following ATEV implantation that requires temporary or permanent discontinuation of antiplatelet or anticoagulant therapy. 20. History of heparin-induced thrombocytopenia. 21. Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities. 22. Immunodeficiency including Human Immunodeficiency Virus (HIV), active autoimmune disease, or on immunosuppressant therapy. 23. Treatment with any investigational drug or device within 60 days prior to study entry or ongoing participation in another clinical study of an investigational product. 24. Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance. 25. Has any other condition, in the opinion of the principal investigator, which would put the patient at increased risk from participating in the study or otherwise prevent participation.
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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 places running it
4 sites. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Medicover
Warsaw, Poland
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Military Institute of Medicine - National Research Institute
Warsaw, Poland
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University Clinical Hospital No. 2 PUM in Szczecin
Szczecin, Poland
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University Clinical Hospital in Poznań
Poznan, Poland
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