New Lab-Made blood vessel tested in heart bypass patients
NCT ID NCT06434935
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early study tests the safety of a new synthetic tube (Vascudyne CAB A) used to reroute blood around blocked heart arteries. Five adults needing bypass surgery will receive this graft alongside standard grafts. Doctors will check if the graft stays open without problems for up to one year.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2024
- Expected to finish
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Aug 2026
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: 1. Patients needing isolated coronary artery bypass grafting to multiple coronary arteries (CA) in which the first target CA shall be an arterial bypass to the left anterior descending artery (LAD) and the second and potentially third target CA must be at least 2 mm in diameter, have at least 70% stenosis proximal to the bypass, have at least Thrombolysis in Myocardial Infarction (TIMI) II flow, and shall be among the following options: right coronary artery (RCA), right posterior descending artery (PDA), Ramus Intermedius, obtuse marginal arteries (OM), or diagonal branches of the left anterior descending artery. 2. Male or female patients between the ages of 45 and 75 years inclusive. 3. Elective patient, selected and accepted by the local Heart Team and confirmed by the Sponsor's Screening Committee for an on-pump full sternotomy CABG surgery. 4. Life expectancy of at least 4 years. 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 computerized tomography (CT) scan. 8. Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the investigational device). 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 coronary artery bypass graft (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. Patients with Type 1 Diabetes and Patients with Type II Diabetes having glycate hemoglobin test (A1C)\>8. 10. Chronic kidney disease with Glomerular Filtration Rate (GFR) \< 45 militers per minute (mL/min), or active dialysis patients 11. Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) \<1.5 lit/sec or 45% predicted forced expiratory volume in one second (FEV1). 12. Patient with known interstitial lung disease, diagnosed by imaging or pulmonary function tests, including diffusing capacity of the lungs for carbon monoxide (DLCO). 13. Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety. 14. Patient on preoperative anticoagulant (i.e. Warfarin) or any known intrinsic coagulation disorder. 15. Abnormal blood values (e.g. leukopenia, anemia, thrombocytopenia, or thrombocytosis with Platelet Count \>400,000 per militer (mL) that could influence graft hemostasis or patient recovery. 16. 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). 17. Any medical intervention or condition within the 12 months following TRUE CAB implantation that requires temporary or permanent discontinuation of anticoagulant therapy. 18. History of heparin-induced thrombocytopenia. 19. Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet and factor Xa inhibitor therapy. 20. Immunodeficiency including AIDS / HIV, active autoimmune disease, or on immunosuppressant therapy. 21. 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. 22. Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance. 23. 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
1 site. 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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Sanatario Italiano
Asunción, Paraguay
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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