Status:
TERMINATED
The eSVS® Mesh Post-Marketing Trial
Lead Sponsor:
Kips Bay Medical, Inc.
Collaborating Sponsors:
University Hospital, Basel, Switzerland
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate patency rates of the eSVS Mesh Saphenous Vein Graph (SVG) and control SVG at six and twenty-four months via coronary angiography and analyses of Duplex Sonogra...
Detailed Description
This Study will enroll up to 100 patients total. Patients will be enrolled upon meeting certain inclusion criteria, including GSV duplex-sonography results and consent. They will be enrolled based on ...
Eligibility Criteria
Inclusion
- Patients requiring SVG CABG of the Right Coronary Artery (RCA) AND the Circumflex Artery (Cx) Systems due to atherosclerotic coronary artery disease in both of the two vessels with equal to or greater than 75% stenosis at a single site or multiple stenosis of less than 75%
- Patient with approximately sized and accessible target coronary arteries, with a minimal diameter of 1.5mm and a lack of severe calcification at the anastomotic site
- On-pump, off-pump and beating heart (beating heart with cardiopulmonary bypass) CABG.
- SVG's (eSVS Mesh treated AND non-meshed control vein graft) complying with the size requirements as outlined in the eSVS Mesh "Instructions for Use"
- CABG operational procedure must allow an eSVS Mesh implant procedure as to the eSVS Mesh Instructions for Use
- Patients equal to or greater than 21 years of age
- German language (mother tongue or fully comprehensive patients)
- Any other language with appropriate translation (fully comprehensive patients)
- The patient's accordance to CABG confirmed by a signed standardized internal informed consent for CABG
- Patient able to give their informed written consent
Exclusion
- Patients not able to give their informed written consent
- No appropriate target coronary vessel (impaired accessibility, less than 1.5mm diameter, severe calcification)
- SVG's (eSVS Mesh treated AND non-meshed control venous graft) NOT complying with the size requirements as outlined in the eSVS Mesh Instructions for Use
- CABG operational procedure, that DO NOT ALLOW an eSVS Mesh implant procedure as to the eSVS Mesh Instructions for Use
- Concomitant non-CABG cardiac procedure(s)
- Prior cardiac surgery
- Concomitant disease likely to limit life expectancy to less than 2 years
- inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)
- Inability to comply with required follow-ups, including angiography imaging methods (allergy to contrast medium, renal insufficiency with creatnine level greater than 150 mmol/l)
- Patients with a known or suspected infection in the field of operation
- Patient is pregnant or intends to become pregnant within 24 months
- Non-pregnant Patient of childbearing potential, who is not prepared for contraception during the study-period
- Concurrent participation in another interventional trial (excluding observational/survey studies)
- Foreign language (no entire comprehension of the patient information and informed study consent guaranteed)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01520311
Start Date
January 1 2012
End Date
September 1 2015
Last Update
June 29 2016
Active Locations (1)
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1
University Hospital
Basel, Switzerland, CH-4031