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Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VEST supported | Experimental | Vein graft supported by VEST |
|
| Control | Active Comparator | Vein grafts unsupported by VEST |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEST External Support | Device |
| ||
| Coronary Artery Bypass Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones. | Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Intimal hyperplasia area | Sub group (IVUS) - Intimal hyperplasia (plaque+media) area [mm2] as assessed by IVUS | 2 years |
| MACCE | Composite of: All-cause mortality; Stroke; Myocardial infarction; Coronary revascularization |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Innsbruck | Austria | ||||
| Medical University of Vienna |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29373645 | Derived | Amin S, Werner RS, Madsen PL, Krasopoulos G, Taggart DP. Influence of external stenting on venous graft flow parameters in coronary artery bypass grafting: a randomized study. Interact Cardiovasc Thorac Surg. 2018 Jun 1;26(6):926-931. doi: 10.1093/icvts/ivy007. |
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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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| ID | Term |
|---|---|
| D001026 | Coronary Artery Bypass |
| ID | Term |
|---|---|
| D009204 | Myocardial Revascularization |
| D006348 | Cardiac Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Procedure |
|
|
| 2 years |
| Vein graft failure | Defined as ≥50% stenosis by QCA | 2 years |
| Early vein graft failure | Early vein graft failure, defined as >50% occlusion by CT Angio | 6 months |
| Vienna |
| Austria |
| German Heart Center | Berlin | Germany |
| Immanuel Hospital Bernau. Brandenburg Heart Center | Bernau | Germany |
| University Hospital of Cologne | Cologne | Germany |
| West-German Heart Center Essen University | Essen | Germany |
| University Medical Center Schleswig-Holstein | Lübeck | Germany |
| Krankenhaus der Barmherzigen Bruder | Trier | Germany |
| Rambam - Health Care Campus | Haifa | Israel |
| Sheba Medical Center Hospital | Ramat Gan | Israel |
| Papworth Hospital | Papworth Everard | Cambridge | United Kingdom |
| Blackpool Victoria Hospital | Blackpool | United Kingdom |
| University Hospitals Bristol | Bristol | United Kingdom |
| The John Radcliffe Hospital | Oxford | United Kingdom |
| University Hospital Southampton | Southampton | United Kingdom |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D058017 | Vascular Grafting |
| D014656 | Vascular Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |