The eSVS (TM) Mesh External Saphenous Vein Support Trial

Launched by NATIONAL UNIVERSITY HOSPITAL, SINGAPORE · Oct 21, 2008

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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
• • 2. 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
• • 3. are able to give their informed written consent
• • 4. are ≥ 21 years of age
• Exclusion Criteria:
• • 1. no appropriate target coronary vessel
• • 2. discreet attachment of each SVG to the aorta is not possible (non-consecutive or "jump" grafts are excluded)
• • 3. concomitant non-CABG cardiac procedure
• • 4. prior peripheral vascular or cardiac surgery
• • 5. prior stroke
• • 6. history of atrial fibrillation
• • 7. diffuse peripheral vascular disease
• • 8. age \> 80
• • 9. LVEF \< 30% at time of enrollment
• • 10. Insulin-dependent diabetes
• • 11. concurrent participation in another trial
• • 12. concomitant life-threatening disease likely to limit life expectancy to less than 2 years
• • 13. contra-indications to on-pump CABG with cardioplegic arrest (calcified aorta, calcified coronaries, small target vessels)
• • 14. emergency CABG surgery
• • 15. inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)
• • 16. taking warfarin or clopidogrel at the time of surgery
• • 17. inability to comply with required follow-ups, including angiography imaging methods
• • 18. patient is pregnant or intends on becoming pregnant in the next 12 months