Tests a new tissue-engineered blood vessel for heart bypass surgery

Trial details

Who runs it

Vascudyne, Inc.

Trial code

NCT07078370

Record updated

29 July 2026

Original description

To assess safety and feasibility of a coronary bypass created with Vascudyne Acellular Tissue Engineered Vessel (ATEV) with External Support Structure (ESS) in patients requiring multi vessel coronary artery bypass grafting (CABG).Read full original descriptionShow less

Safety Study of Vascudyne's Small Diameter Acellular Tissue Engineered Vessel (ATEV) for Coronary Artery Bypass

To assess safety and feasibility of a coronary bypass created with Vascudyne Acellular Tissue Engineered Vessel (ATEV) with External Support Structure (ESS) in patients requiring multi vessel coronary artery bypass grafting (CABG).

Inclusion: Subjects must meet ALL of the following inclusion criteria:; Patient with limited quantity of good quality saphenous vein graft (SVG) for planned operation per the surgeon discretion; 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; Male or female patients between the ages of 45 and 75 years inclusive; 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; 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); Patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent; 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); Patient is willing to be compliant with prescribed anticoagulant therapy (critical to preventing thrombus in the ATEV).

Exclusion: Patients requiring emergency surgery; Patients with any prior open cardiac surgery such as CABG; Any planned concomitant cardiac surgery, including but not limited to: valve surgery, repair of intracardiac shunt, surgical arrhythmia ablation; Concomitant life-threatening disease likely to limit life expectancy to less than 2 years; 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; History of cardiac resynchronization therapy (CRT) or implantable cardioverter defibrillator (ICD) implantation; Myocardial infarction (MI) within 21 days or cerebral vascular accident (CVA) within 90 days of the CABG procedure; Moderate to severe chronic obstructive pulmonary disease (COPD) with a forced expiratory volume (FEV) <1.5 L/sec or 45% predicted FEV1; Patient with known interstitial lung disease, diagnosed by imaging or pulmonary function tests, including Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO); Endocarditis, pericarditis, or any other active systemic infection that would interfere with patient safety; Patient on preoperative anticoagulant, or pre existing indication for anticoagulation (e.g. atrial fibrillation, history of thromboembolism), or with known coagulation disorder; 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); Contraindication to or known serious allergy to anticoagulant, aspirin, or planned antiplatelet (clopidogrel, ticagrelor, prasugrel) and factor Xa inhibitor therapy; Any planned medical intervention or condition within the 12 months following ATEV implantation that requires temporary or permanent discontinuation of antiplatelet or anticoagulant therapy; History of heparin-induced thrombocytopenia; Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities; Immunodeficiency including Human Immunodeficiency Virus (HIV), active autoimmune disease, or on immunosuppressant therapy; 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; Patients with left ventricular ejection fraction < 35%; Patient with uncontrolled diabetes (glycated hemoglobin > 8%); 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)); 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; Patients with diffusely diseased coronary arteries suggestive of either poor target quality, or poor vessel runoff; Patients with cardiogenic shock; Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.

ClinicalTrials.gov NCT07078370