The eSVS® Mesh Randomized Post-Market Study

Kips Bay Medical

Status: Terminated

Conditions: Coronary Artery Disease; Myocardial Ischemia; Arterial Occlusive Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Heart Diseases; Coronary Disease

Treatments: Device: eSVS® Mesh

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01462721

11-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

SVG + eSVS Mesh vs Control SVG

Other group

Description:

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.

Treatment:

Device: eSVS® Mesh