The eSVS® Mesh Randomized Post-Market Study

Not Applicable

Terminated

• Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases
• Interventions: Device: eSVS® Mesh

• Registration Number: NCT01462721
• Lead Sponsor: Kips Bay Medical, Inc.

Brief 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.

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-31
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-27
• Last Update Posted: 2014-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Patient has been diagnosed with multi-vessel coronary artery disease
• Requires Saphenous Vein Graft (SVG) Coronary Artery Bypass Graft (CABG) surgery of the Right Coronary Artery (RCA) and the Circumflex Artery (Cx) systems due to atherosclerotic coronary artery disease
• SVGs (eSVS Mesh AND Control) meet size requirements as outlined in eSVS Mesh Instructions for Use
• eSVS Mesh implant procedure can be performed as outlined in the eSVS Mesh Instructions for Use
• Are able to give their informed consent

Exclusion Criteria

• Not able to give informed consent
• No appropriate target coronary vessels
• SVGs (eSVS Mesh or Control) do not meet size requirements as outlined in eSVS Mesh Instructions for Use
• eSVS Mesh implant procedure cannot be performed as outlined in the eSVS Mesh Instructions for Use
• Inability to tolerate or comply with normal post-surgical drug regimen
• Inability to comply with required follow-up coronary angiography/CT

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SVG + eSVS Mesh vs Control SVG	eSVS® Mesh	Either the Circumflex Coronary Artery (Cx) or the Right Coronary Artery (RCA) will receive the mesh supported vein graft and the native saphenous vein as second and control graft.

Primary Outcome Measures

Name	Time	Method
Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG	3-6 Months	Patency of eSVS Mesh and Control SVGs assessed by spiral CT or angiography at 3-6 months following surgery.
Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts	24 Months	Patency and percent stenosis of the eSVS Mesh and Control SVGs assessed by angiography at 24 months following surgery
The occurrence of any Major Adverse Cardiac Event (MACE)	3-6 months post implant	The occurrence of the MACE composite of death, myocardial infarction (Q wave and non-Q wave), stroke, coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention), and at 3 to 6-months postimplant.

Trial Locations

Locations (1)

University Hospital of Kiel; 🇩🇪 Kiel, Germany