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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

October 26, 2011
February 5, 2013
October 2011
October 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01462721 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The eSVS® Mesh Randomized Post-Market Study
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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Myocardial Ischemia
  • Coronary Disease
  • Heart Diseases
  • Cardiovascular Diseases
  • Arteriosclerosis
  • Arterial Occlusive Diseases
  • Vascular Diseases
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
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.
Intervention: Device: eSVS® Mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
December 2017
October 2013   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01462721
11-001
Yes
Kips Bay Medical, Inc.
Kips Bay Medical, Inc.
University of Schleswig-Holstein
Study Director: Randy LaBounty Kips Bay Medical, Inc.
Kips Bay Medical, Inc.
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP