Status:
UNKNOWN
The eSVS (TM) Mesh External Saphenous Vein Support Trial
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Kips Bay Medical, Inc.
Transmedic Pte Ltd, Singapore
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
21-80 years
Phase:
PHASE2
Brief Summary
Prospective, multi-center, randomized, controlled (patients as their own control) trial on an external mesh device (eSVS™, Kips Bay Medical) supporting saphenous vein grafts for coronary bypass graft ...
Detailed Description
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 ar...
Eligibility Criteria
Inclusion
- require on-pump SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease, with ≥ 75% stenosis in each of these vessels
- have appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and a lack of calcification at the anastomotic site
- are able to give their informed written consent
- are ≥ 21 years of age
Exclusion
- no appropriate target coronary vessel
- discreet attachment of each SVG to the aorta is not possible (non-consecutive or "jump" grafts are excluded)
- concomitant non-CABG cardiac procedure
- prior peripheral vascular or cardiac surgery
- prior stroke
- history of atrial fibrillation
- diffuse peripheral vascular disease
- age \> 80
- LVEF \< 30% at time of enrollment
- Insulin-dependent diabetes
- concurrent participation in another trial
- concomitant life-threatening disease likely to limit life expectancy to less than 2 years
- contra-indications to on-pump CABG with cardioplegic arrest (calcified aorta, calcified coronaries, small target vessels)
- emergency CABG surgery
- inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)
- taking warfarin or clopidogrel at the time of surgery
- inability to comply with required follow-ups, including angiography imaging methods
- patient is pregnant or intends on becoming pregnant in the next 12 months
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00777777
Start Date
August 1 2008
End Date
September 1 2009
Last Update
October 22 2008
Active Locations (1)
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1
Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
Singapore, Singapore, 119074