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Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| eSVS Mesh treated saphenous vein graft | Active Comparator | Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system. |
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| Control saphenous vein graft | Sham Comparator | Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system. |
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| Single Vessel Treatment | Active Comparator | Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSVS Mesh treated saphenous vein graft | Device | During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system. |
| Measure | Description | Time Frame |
|---|---|---|
| MACE | The rate of major adverse coronary events (MACE) defined as the rate of the composite of total mortality, MI (Q wave and non Q wave), and/or coronary target vessel revascularization (percutaneous coronary intervention or CABG). | 30 days |
| SVG patency determined by angiography | Angiographic patency rate of the enrolled grafts defined as < 50% stenosis. | 6 months |
| Technical success implanting eSVS Mesh | Technical success defined as successful placement of the eSVS Mesh on the saphenous vein and surgical implantation of the SVG. | intra-operative |
| Measure | Description | Time Frame |
|---|---|---|
| MACCE and mediastinitis | MACE, MACCE, MI and all mortality rates through five years, mediastinitis rate through 6 months. | 5 years |
| SVG patency determined by angiography | Angiographic patency rate of the enrolled grafts defined as < 75%. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Wetterling | Contact | 763-235-3540 | clinical@kipsbaymedical.com |
| Name | Affiliation | Role |
|---|---|---|
| Lars Englberger, MD | University of Bern | Principal Investigator |
| John Puskas, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital Midtown | Recruiting | Atlanta | Georgia | 30308 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 5, 2015 | |
| Reset | Oct 26, 2015 | |
| Release | Jun 28, 2016 |
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| Control saphenous vein graft | Other | During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system. |
|
| 6 months |
| Plaque burden | Plaque burden of the enrolled grafts as assessed by IVUS imaging (IVUS Sub-Study). | 6 months |
| Northeast Georgia Heart Center | Recruiting | Gainesville | Georgia | 30501 | United States |
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| Mayo Clinic / St. Mary's Hospital | Recruiting | Rochester | Minnesota | 55905 | United States |
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| The Valley Hospital | Recruiting | Ridgewood | New Jersey | 07450 | United States |
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| Lenox Hill Hospital | Recruiting | New York | New York | 10075 | United States |
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| General University Hospital | Recruiting | Prague | Czechia |
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| Hospital na Homolce | Recruiting | Prague | Czechia |
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| University Hospital Kralovske Vinohrady | Active, not recruiting | Prague | Czechia |
| C.H.U. Dupuytren | Recruiting | Limoges | France |
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| Bordeaux University Hospital | Recruiting | Pessac | France |
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| Lancisi Hospital | Recruiting | Ancona | Italy |
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| Heart Hospital - G. Monasterio Tuscany Foundation for Health & Research | Recruiting | Massa | Italy |
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| Catharina Ziekenhuis | Recruiting | Eindhoven | Netherlands |
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| University Hospital of Bern | Recruiting | Bern | 3010 | Switzerland |
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| Royal Brompton Hospital | Recruiting | London | SW3 6NP | United Kingdom |
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| Reset | Aug 9, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 5, 2015 | Oct 26, 2015 | |||
| Jun 28, 2016 | Aug 9, 2016 |