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The eSVS® Mesh Randomized Post-Market Study

Primary Purpose

Coronary Artery Disease, Myocardial Ischemia, Coronary Disease

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
eSVS® Mesh
Sponsored by
Kips Bay Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital of Kiel

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

SVG + eSVS Mesh vs Control SVG

Arm 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.

Outcomes

Primary Outcome Measures

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.
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
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.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2011
Last Updated
February 27, 2014
Sponsor
Kips Bay Medical, Inc.
Collaborators
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT01462721
Brief Title
The eSVS® Mesh Randomized Post-Market Study
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kips Bay Medical, Inc.
Collaborators
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Myocardial Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SVG + eSVS Mesh vs Control SVG
Arm Type
Other
Arm 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.
Intervention Type
Device
Intervention Name(s)
eSVS® Mesh
Other Intervention Name(s)
eSVS Mesh, eMesh, external Saphenous Vein Support Mesh
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG
Description
Patency of eSVS Mesh and Control SVGs assessed by spiral CT or angiography at 3-6 months following surgery.
Time Frame
3-6 Months
Title
Patency and percent stenosis of the eSVS Mesh and Control Saphenous Vein Grafts
Description
Patency and percent stenosis of the eSVS Mesh and Control SVGs assessed by angiography at 24 months following surgery
Time Frame
24 Months
Title
The occurrence of any Major Adverse Cardiac Event (MACE)
Description
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.
Time Frame
3-6 months post implant

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy LaBounty
Organizational Affiliation
Kips Bay Medical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

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The eSVS® Mesh Randomized Post-Market Study

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