Safety Study of Acellular Tissue Engineered Vessel for Coronary Artery Bypass

Official title

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

Overview

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

• Device ATEV 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

Primary outcome measures

• Successful implantation [Time frame: 30 days.]
• Freedom from Major Adverse Cardiac and Cerebrovascular events (MACCE) at 30 days. [Time frame: 30 days.]

Secondary outcome measures (6)

• Patency at 1 and 6 months [Time frame: 1 month and 6 months.]
• Patency at 12 months [Time frame: 12 months.]
• Lumen Diameter Uniformity [Time frame: 12 months.]
• Immune Response [Time frame: 12 months.]
• Device Serious Adverse Event (SAE) [Time frame: 6 months, 12 months, 24 months, 48 months, and 60 months.]
• Freedom from (major adverse cardiac and cerebrovascular events) MACCE [Time frame: 6 months, 12 months, 24 months, 48 months, and 60 months.]

Eligibility criteria

Inclusion criteria

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 criteria

• Patients with left ventricular ejection fraction < 35%.
• Patients with diffusely diseased coronary arteries suggestive of either poor target quality, or poor vessel runoff.
• Patients requiring emergency surgery.
• Patients with cardiogenic shock.
• 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.
• 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.
• Concomitant life-threatening disease likely to limit life expectancy to less than 2 years.
• 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)).
• 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.
• 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
• 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.
• 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.
• Subject has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Poland · 4 centers

• University Clinical Hospital in Poznań — Poznan
• University Clinical Hospital No. 2 PUM in Szczecin — Szczecin
• Medicover — Warsaw
• Military Institute of Medicine - National Research Institute — Warsaw

Identifiers

NCT: NCT07078370 · CIP-004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗