NCT01676376

The eMESH 1 Feasibility Study

A Multi-center, International Study of External Saphenous Vein Support Using eSVS® Mesh in CABG Surgery: The eMESH I Study

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Kips Bay Medical, Inc. · Industry
• Sex: All
• Age: 21 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

Conditions

• Atherosclerosis of Autologous Vein Coronary Artery Bypass Graft(s)

Interventions

Type	Name	Description
DEVICE	eSVS Mesh treated saphenous vein graft	During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
OTHER	Control saphenous vein graft	During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-12-01
• Completion: 2020-06-01
• First posted: 2012-08-30
• Last updated: 2015-02-19

Locations

15 sites across 7 countries: United States, Czechia, France, Italy, Netherlands, Switzerland, United Kingdom