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The eSVS® Mesh Randomized Post-Market Study

This study has been terminated.
(Study design led to enrollment barriers.)
Sponsor:
Collaborator:
University of Schleswig-Holstein
Information provided by (Responsible Party):
Kips Bay Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01462721
First received: October 26, 2011
Last updated: February 5, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Device: eSVS® Mesh

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kips Bay Medical, Inc.:

Primary Outcome Measures:
  • Patency of external Saphenous Vein Support (eSVS) Mesh Saphenous Vein Graft (SVG) versus Control SVG [ Time Frame: 3-6 Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
    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) [ Time Frame: 3-6 months post implant ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 12
Study Start Date: October 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
  • eSVS Mesh
  • eMesh
  • external Saphenous Vein Support Mesh

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462721

Locations
Germany
University Hospital of Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
Kips Bay Medical, Inc.
University of Schleswig-Holstein
Investigators
Study Director: Randy LaBounty Kips Bay Medical, Inc.
  More Information

No publications provided

Responsible Party: Kips Bay Medical, Inc.
ClinicalTrials.gov Identifier: NCT01462721     History of Changes
Other Study ID Numbers: 11-001
Study First Received: October 26, 2011
Last Updated: February 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
 Coronary Disease
Heart Diseases
Ischemia
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013