The Vascudyne Coronary Artery Bypass Study (VCAB-1) is an initial safety and feasibility study of the Vascudyne, Inc. Coronary Artery Bypass Conduit (CAB A) for bypass of stenosed native coronary arteries in patients undergoing coronary artery bypass surgery.
Prospective, non-randomized, initial evaluation clinical study to assess the feasibility of TRUE CAB for secondary coronary targets in patients needing multiple coronary artery bypass. Patients will be implanted with a single TRUE CAB 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 saphenous vein shall be used for any additional targets as needed. Estimated enrollment for first three patients (2 weeks), followed by enrollment over 4 months. Follow up through 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Coronary Bypass
Sanatario Italiano
Asunción, Paraguay
Patency
Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
Time frame: 6 months
Major Adverse Cardiac and Cerebrovascular events (MACCE)
Freedom from MACCE; includes adverse events; death, non-fatal myocardial infraction, non-fatal stroke, unplanned revascularization, and hospitalization due to heart failure
Time frame: 30 days
Patency
Intervention-free angiographic patency \[failure defined as \>50% stenosis or occlusion\].
Time frame: 30 days, 12 months, 18 months and 24 months
Fitzgibbon classification
Fitzgibbon classification is a grading system for coronary artery bypass grafts (CABGs) that use saphenous vein grafts (SVGs) and arterial grafts to treat severe coronary artery disease. The scale assesses the following characteristics: Fitzgibbon I patency (perfect patency) with no lumen irregularities. Fitzgibbon II patency with lumen irregularities that involve less than 50% of SVG length. Fitzgibbon III patency with lumen irregularities that involve more than 50% of SVG length
Time frame: 30 days, 6 months and 12 months
MACCE
Freedom from MACCE includes adverse events; death, non-fatal myocardial infraction, non-fatal stroke, unplanned revascularization, and hospitalization due to heart failure
Time frame: 6, 12, 18 and 24 months
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