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The eSVS® Mesh Randomized Post-Market Study

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ClinicalTrials.gov Identifier: NCT01462721
Recruitment Status : Terminated
First Posted : October 31, 2011
Last Update Posted : February 28, 2014
Sponsor:
Collaborator:
University of Schleswig-Holstein
Information provided by (Responsible Party):
Kips Bay Medical, Inc.

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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Device: eSVS® Mesh Not Applicable

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  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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.

Responsible Party: Kips Bay Medical, Inc.
ClinicalTrials.gov Identifier: NCT01462721     History of Changes
Other Study ID Numbers: 11-001
First Posted: October 31, 2011    Key Record Dates
Last Update Posted: February 28, 2014
Last Verified: February 2014

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