Status:
TERMINATED
The eSVS® Mesh Randomized Post-Market Study
Lead Sponsor:
Kips Bay Medical, Inc.
Collaborating Sponsors:
University Hospital Schleswig-Holstein
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
Phase:
NA
Brief Summary
The purpose of this study is to evaluate patency rates of the external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Grafts (SVG) and Control SVG at 3-6 months and 24 months.
Detailed Description
The study will enroll up to 200 patients at up to 6 sites. Patients will be enrolled upon meeting entrance criteria, including obtaining written informed consent. Eligible patients must be clinically ...
Eligibility Criteria
Inclusion
- Patient has been diagnosed with multi-vessel coronary artery disease
- Requires Saphenous Vein Graft (SVG) Coronary Artery Bypass Graft (CABG) surgery of the Right Coronary Artery (RCA) and the Circumflex Artery (Cx) systems due to atherosclerotic coronary artery disease
- SVGs (eSVS Mesh AND Control) meet size requirements as outlined in eSVS Mesh Instructions for Use
- eSVS Mesh implant procedure can be performed as outlined in the eSVS Mesh Instructions for Use
- Are able to give their informed consent
Exclusion
- Not able to give informed consent
- No appropriate target coronary vessels
- SVGs (eSVS Mesh or Control) do not meet size requirements as outlined in eSVS Mesh Instructions for Use
- eSVS Mesh implant procedure cannot be performed as outlined in the eSVS Mesh Instructions for Use
- Inability to tolerate or comply with normal post-surgical drug regimen
- Inability to comply with required follow-up coronary angiography/CT
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01462721
Start Date
October 1 2011
End Date
February 1 2013
Last Update
February 28 2014
Active Locations (1)
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1
University Hospital of Kiel
Kiel, Germany, 24105