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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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
University Clinical Hospital in Poznań
Poznan, Poland
University Clinical Hospital No. 2 PUM in Szczecin
Szczecin, Poland
Medicover
Warsaw, Poland
Military Institute of Medicine - National Research Institute
Warsaw, Poland
Successful implantation
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.
Time frame: 30 days.
Freedom from Major Adverse Cardiac and Cerebrovascular events (MACCE) at 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
Time frame: 30 days.
Patency at 1 and 6 months
Patency of conduit assessed by Coronary Computed Tomography Angiography (CCTA) results at 1 and 6 months post-implantation.
Time frame: 1 month and 6 months.
Patency at 12 months
Patency of conduit assessed by angiography results at 12 months, defined according to Fitzgibbon classification.
Time frame: 12 months.
Lumen Diameter Uniformity
Lumen Diameter Uniformity of all bypasses assessed by angiography results at 12 months.
Time frame: 12 months.
Immune Response
Panel Reactive Antibody assessment via serum assay at baseline, 1, 6, and 12 months.
Time frame: 12 months.
Device Serious Adverse Event (SAE)
Device Related Serious Adverse Events identified at 6, 12, 24, 48 and 60 months follow-ups.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 6 months, 12 months, 24 months, 48 months, and 60 months.
Freedom from (major adverse cardiac and cerebrovascular events) MACCE
Freedom from (major adverse cardiac and cerebrovascular events) MACCE at 6, 12, 24, 48 and 60 months follow-ups.
Time frame: 6 months, 12 months, 24 months, 48 months, and 60 months.