A prospective, single arm, non-randomized FIH feasibility study to evaluate the preliminary safety and performance of the XABG technology in patients with multi-vessel atherosclerotic coronary artery disease, scheduled by the local Heart Team to undergo elective coronary artery bypass (CABG) surgery.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Elective, coronary artery bypass (CABG) surgery. Each study subject will receive an left internal mammary artery (LIMA) conduit to the left anterior descending (LAD) coronary artery. Patients with uncompromised saphenous veins will receive a SVG to the LCX or RCA and the XABG to the remaining territory. Patients with compromised arterial and/or saphenous veins, (i.e., "no-vein" patients), will receive one XABG to the LCX or RCA to achieve incomplete revascularization.
UZ Leuven
Leuven, Belgium
Vilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
John Paul II Hospital Krakow
Krąków, Poland
Medicover Hospital
Warsaw, Poland
Procedural success during the first 30 days
XABG technology performs as intended with successful proximal and distal anastomoses and graft patency at the conclusion of the procedure and at 30 days. Patency is defined as a diameter stenosis less than 50%
Time frame: 30 days
Freedom from device related Serious Adverse Events (SAEs)
Time frame: 30 days
Intimal hyperplasia area
Assessed by OCT
Time frame: 12 months
Graft patency
Patency defined as a diameter stenosis less than 50%
Time frame: 30 days, 6 months, 12 months
Lumen diameter uniformity
Using Fitzgibbon's 3-point ordinal uniformity scale
Time frame: 30 days, 6 months, 12 months
Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Absence of device related SAEs
Time frame: 30 days, 6 months, 12 months, and yearly until 5 years
Freedom from vein harvesting related wound infection, non-infective wound healing disturbances, and leg pain
Leg pain will be assessed by standard 10-point VAS scale and presented as descriptive statistics
Time frame: 30 days and 6 months
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