Clinical Trials Directory

Trials / Terminated

TerminatedNCT01462721

The eSVS® Mesh Randomized Post-Market Study

Post-market Study to Evaluate Post-implant Patency Rates of the External Saphenous Vein Support (eSVS®) Mesh in the Treatment of Saphenous Vein Grafts (SVGs) During Coronary Artery Bypass Grafting (CABG) Versus SVGs Without the eSVS Mesh.

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
12 (actual)
Sponsor
Kips Bay Medical, Inc. · Industry
Sex
All
Age
—
Healthy volunteers
Not accepted

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 indicated for coronary artery bypass grafting (CABG) using autologous saphenous vein grafts (SVG). The study is a prospective, randomized, repeated measure controlled trial based on each patient receiving one control SVG and one external Saphenous Vein Support (eSVS) Mesh treated SVG. Each patient will be their own control.

Conditions

Interventions

TypeNameDescription
DEVICEeSVS® MeshPatients with multi-vessel coronary artery disease who require saphenous vein graft (SVG) coronary artery bypass graft (CABG) surgery of the Right coronary Artery (RCA) and the Circumflex Artery (Cx) due to atherosclerotic coronary artery disease will serve as their own control. They will be randomized to either an SVG+eSVS Mesh to the RCA and an SVG to the Cx or an SVG to the RCA and an SVG+eSVS Mesh to the Cx.

Timeline

Start date
2011-10-01
Primary completion
2013-02-01
Completion
2013-02-01
First posted
2011-10-31
Last updated
2014-02-28

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT01462721. Inclusion in this directory is not an endorsement.