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| Name | Class |
|---|---|
| Kips Bay Medical, Inc. | INDUSTRY |
| Transmedic Pte Ltd, Singapore | UNKNOWN |
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Prospective, multi-center, randomized, controlled (patients as their own control) trial on an external mesh device (eSVSā¢, Kips Bay Medical) supporting saphenous vein grafts for coronary bypass graft surgery in patients with multi-vessel coronary heart disease.
The objective of the eSVS⢠Mesh Saphenous Vein Support Trial is to prospectively evaluate the clinical safety and efficacy of the eSVS⢠Mesh for the treatment of Saphenous Vein Graft (SVG) Coronary artery bypass grafting (CABG) versus SVG CABG without an eSVS⢠Mesh.
The eSVS⢠Mesh External Saphenous Vein Support Trial is a prospective, multi-center, randomized, controlled trial enrolling up to 120 patients with multi-vessel coronary artery disease who require SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease. Patients will serve as their own control (patients will be randomized to either:
Clinical follow-up assessments consisting of a physical exam, laboratory testing, medication review, and adverse event monitoring for all enrolled patients will be performed at 30 days, 6 months and 12 months. In addition, the 12 month follow-up assessment will include angiography.
The investigational device being evaluated in this clinical trial is an External Saphenous Vein Support device, the eSVS⢠Mesh.
The eSVS⢠Mesh is an extravascular prosthesis consisting of a highly flexible, semi-compliant knitted nitinol mesh tube that is placed over the patient's saphenous vein graft (SVG) during coronary artery bypass grafting (CABG). The eSVS⢠Mesh is designed to:
The eSVS⢠Mesh has compliance characteristics comparable to native internal thoracic arteries. Since the eSVS⢠Mesh vascular prosthesis is made of nitinol, it is highly kink resistant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Either the Circumflex Coronary Artery or the Right Coronary Artery will receive the mesh supported vein graft and the native saphenous vein as second and control graft. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| eSVS, saphenous vein supporting mesh | Device | Surgical coronary artery bypass grafting to the right coronary artery and the circumflex coronary artery with saphenous vein grafts, one will be supported by the eSVS(TM). |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery | 12 months | |
| Primary Safety Endpoint: The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at 30 days post surgery | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at discharge, 6 months and 12 months post surgery | 12 months | |
| Per-patient incidence of vein graft failure/occlusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Uwe Klima, MD, PhD | Contact | 00656772 | 2065 | uwe_klima@nuh.com.sg |
| Theodoros Kofidis, MD, PhD | Contact | 00656772 | 2076 | surtk@nus.edu.sg |
| Name | Affiliation | Role |
|---|---|---|
| Uwe Klima, MD, PhD | Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore | Recruiting | Singapore | 119074 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9461200 | Background | Mehta D, George SJ, Jeremy JY, Izzat MB, Southgate KM, Bryan AJ, Newby AC, Angelini GD. External stenting reduces long-term medial and neointimal thickening and platelet derived growth factor expression in a pig model of arteriovenous bypass grafting. Nat Med. 1998 Feb;4(2):235-9. doi: 10.1038/nm0298-235. | |
| 17992655 | Background |
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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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|
| 12 months |
| Per-graft incidence of vein graft failure/occlusion | 12 months |
| Rates of graft failure due to characterization of anastomotic site failure vs. graft failure | 12 months |
| Klesius AA, Konerding MA, Knez P, Dzemali O, Schmitz-Rixen T, Ackermann H, Moritz A, Kleine P. External stenting with a new polyester mesh reduces neointimal hyperplasia of vein grafts in a sheep model. Int J Artif Organs. 2007 Oct;30(10):930-8. doi: 10.1177/039139880703001011. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |