The eSVS® Mesh Randomized Post-Market Study

NCT01462721 | Terminated DMC

• 1 other identifier: 11-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG

  Patency of eSVS Mesh and Control SVGs assessed by spiral CT or angiography at 3-6 months following surgery.

  3-6 Months

• Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts

  Patency and percent stenosis of the eSVS Mesh and Control SVGs assessed by angiography at 24 months following surgery

  24 Months

• The occurrence of any Major Adverse Cardiac Event (MACE)

  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.

  3-6 months post implant

Study Arms (1)

SVG + eSVS Mesh vs Control SVG

OTHER

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.

Device: eSVS® Mesh

Interventions

eSVS® Mesh DEVICE

Patients 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.

Also known as: eSVS Mesh, eMesh, external Saphenous Vein Support Mesh

SVG + eSVS Mesh vs Control SVG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kips Bay Medical, Inc.: lead
• University Hospital Schleswig-Holstein: collaborator

Study Sites (1)

University Hospital of Kiel

Kiel, 24105, Germany

Location

MeSH Terms

Conditions

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

Study Officials

• Randy LaBounty

  Kips Bay Medical, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2011
• First Posted: October 31, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 28, 2014

Record last verified: 2014-02

Locations

DE (1)