The eSVS® Mesh Randomized Post-Market Study

February 27, 2014 updated by: Kips Bay Medical, Inc.

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Kiel, Germany, 24105
        • University Hospital of Kiel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SVG + eSVS Mesh vs Control SVG
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
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.
Other Names:
  • eSVS Mesh
  • eMesh
  • external Saphenous Vein Support Mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG
Time Frame: 3-6 Months
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
Time Frame: 24 Months
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)
Time Frame: 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.
3-6 months post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kips Bay Medical, Inc.

Collaborators

University Hospital Schleswig-Holstein

Investigators

  • Study Director: Randy LaBounty, Kips Bay Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

October 26, 2011

First Submitted That Met QC Criteria

October 27, 2011

First Posted (Estimate)

October 31, 2011

Study Record Updates

Last Update Posted (Estimate)

February 28, 2014

Last Update Submitted That Met QC Criteria

February 27, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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