Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XABG | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CABG | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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% | 30 days |
| Freedom from device related Serious Adverse Events (SAEs) | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intimal hyperplasia area | Assessed by OCT | 12 months |
| Graft patency | Patency defined as a diameter stenosis less than 50% | 30 days, 6 months, 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Intra-operative Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bart Meuris, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven | Leuven | Belgium | ||||
| Vilnius University Hospital Santaros Klinikos |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Lumen diameter uniformity | Using Fitzgibbon's 3-point ordinal uniformity scale | 30 days, 6 months, 12 months |
| Freedom from Major Adverse Cardiac and Cerebrovascular Events (MACCE) | Absence of device related SAEs | 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 | 30 days and 6 months |
| Vilnius |
| Lithuania |
| John Paul II Hospital Krakow | Krąków | Poland |
| Medicover Hospital | Warsaw | Poland |