Coronary Artery Disease, Multi Vessel Coronary Artery Disease
Conditions
Keywords
CABG, ATEV, Tissue Engineered Vessel, coronary artery disease
Brief summary
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).
Detailed description
Prospective, non-randomized, evaluation clinical study to assess the feasibility of Acellular Tissue Engineered Vessel (ATEV) with External Support Structure (ESS) for secondary coronary targets in patients needing multiple coronary artery bypass. Patients will be implanted with a single ATEV with ESS bypass (single proximal and distal anastomoses) to the second or third coronary arteries (CA) bypass target. The primary target CA shall be bypassed using an arterial graft. The left anterior descending (LAD) CA bypass, if needed, shall be bypassed using the left internal mammary artery (LIMA). A native vessel shall be used for any additional targets as needed.
Interventions
DEVICEATEV with ESS
Patients will be implanted with a single Acellular Tissue Engineered Vessel with External Support Structure bypass (single proximal and distal anastomoses) to the second or third coronary artery bypass target
Sponsors
Vascudyne, Inc.
KCRI
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients will be implanted with a single Acellular Tissue Engineered Vessel with External Support Structure bypass (single proximal and distal anastomoses) to the second or third coronary artery bypass target
Eligibility
Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful implantation | 30 days. | Successful implantation as defined by meeting each of the following points: 1. Completion of both a proximal and distal anastomosis, 2. Placement of ESS, 3. No evidence of ATEV twist or kink on direct visual inspection. |
| Freedom from Major Adverse Cardiac and Cerebrovascular events (MACCE) at 30 days. | 30 days. | Freedom from Major Adverse Cardiac and Cerebrovascular events (MACCE) at 30 days. MACCE is defined as combination of: 1. death, 2. non-fatal stroke, 3. non-fatal myocardial infarction, 4. unplanned revascularization 5. hospitalization due to heart failure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patency at 1 and 6 months | 1 month and 6 months. | Patency of conduit assessed by Coronary Computed Tomography Angiography (CCTA) results at 1 and 6 months post-implantation. |
| Patency at 12 months | 12 months. | Patency of conduit assessed by angiography results at 12 months, defined according to Fitzgibbon classification. |
| Lumen Diameter Uniformity | 12 months. | Lumen Diameter Uniformity of all bypasses assessed by angiography results at 12 months. |
| Immune Response | 12 months. | Panel Reactive Antibody assessment via serum assay at baseline, 1, 6, and 12 months. |
| Device Serious Adverse Event (SAE) | 6 months, 12 months, 24 months, 48 months, and 60 months. | Device Related Serious Adverse Events identified at 6, 12, 24, 48 and 60 months follow-ups. |
| Freedom from (major adverse cardiac and cerebrovascular events) MACCE | 6 months, 12 months, 24 months, 48 months, and 60 months. | Freedom from (major adverse cardiac and cerebrovascular events) MACCE at 6, 12, 24, 48 and 60 months follow-ups. |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORKrzysztof Wrobel, MD PhD
MEDICOVER SP Z O.O.
Outcome results
None listed