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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| True CABA | Experimental | Patients will be implanted with a single TRUE CAB bypass (single proximal and distal anastomoses) to the second or third CA bypass target |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CABA | Combination Product | Coronary Bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patency | Intervention-free angiographic patency [failure defined as >50% stenosis or occlusion]. | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patency | Intervention-free angiographic patency [failure defined as >50% stenosis or occlusion]. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adrian Ebner, MD | Italian Hospital Asuncion Paraguay | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanatario Italiano | Asunción | Paraguay |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 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 | 6, 12, 18 and 24 months |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |