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The eSVS (TM) Mesh External Saphenous Vein Support Trial (eSVS)

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ClinicalTrials.gov Identifier: NCT00777777
Recruitment Status : Unknown
Verified October 2008 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : October 22, 2008
Last Update Posted : October 22, 2008
Sponsor:
Collaborators:
Kips Bay Medical, Inc.
Transmedic Pte Ltd, Singapore
Information provided by:
National University Hospital, Singapore

Study Description
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Brief Summary:
Prospective, multi-center, randomized, controlled (patients as their own control) trial on an external mesh device (eSVS™, Kips Bay Medical) supporting saphenous vein grafts for coronary bypass graft surgery in patients with multi-vessel coronary heart disease.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: eSVS, saphenous vein supporting mesh Phase 2

Detailed Description:

The objective of the eSVS™ Mesh Saphenous Vein Support Trial is to prospectively evaluate the clinical safety and efficacy of the eSVS™ Mesh for the treatment of Saphenous Vein Graft (SVG) Coronary artery bypass grafting (CABG) versus SVG CABG without an eSVS™ Mesh.

The eSVS™ Mesh External Saphenous Vein Support Trial is a prospective, multi-center, randomized, controlled trial enrolling up to 120 patients with multi-vessel coronary artery disease who require SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease. Patients will serve as their own control (patients will be randomized to either:

  1. SVG+eSVS™ Mesh at Right Coronary Artery and SVG at Circumflex Artery or
  2. SVG at Right Coronary Artery and SVG+eSVS™ Mesh at Circumflex Artery).

Clinical follow-up assessments consisting of a physical exam, laboratory testing, medication review, and adverse event monitoring for all enrolled patients will be performed at 30 days, 6 months and 12 months. In addition, the 12 month follow-up assessment will include angiography.

The investigational device being evaluated in this clinical trial is an External Saphenous Vein Support device, the eSVS™ Mesh.

The eSVS™ Mesh is an extravascular prosthesis consisting of a highly flexible, semi-compliant knitted nitinol mesh tube that is placed over the patient's saphenous vein graft (SVG) during coronary artery bypass grafting (CABG). The eSVS™ Mesh is designed to:

  • provide radial support to the vein to prevent graft dilatation
  • reduce the vein graft diameter to more closely match target coronary artery diameter
  • provide a more uniform lumen
  • improve blood flow characteristics
  • mitigate the development of intimal hyperplasia and graft stenosis

The eSVS™ Mesh has compliance characteristics comparable to native internal thoracic arteries. Since the eSVS™ Mesh vascular prosthesis is made of nitinol, it is highly kink resistant.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The eSVS(TM)Mesh External Saphenous Vein Support Trial
Study Start Date : August 2008
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : September 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Either the Circumflex Coronary Artery or the Right Coronary Artery will receive the mesh supported vein graft and the native saphenous vein as second and control graft.
 Device: eSVS, saphenous vein supporting mesh
Surgical coronary artery bypass grafting to the right coronary artery and the circumflex coronary artery with saphenous vein grafts, one will be supported by the eSVS(TM).
Other Name: eSVS™; Kips Bay Medical


Outcome Measures
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Primary Outcome Measures :
  1. Primary Efficacy Endpoint: The primary endpoint of the trial is percent stenosis of Study Vessels, assessed by angiography at 12 months following surgery [ Time Frame: 12 months ]
  2. Primary Safety Endpoint: The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at 30 days post surgery [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The occurrence of the composite of total mortality, stroke, MI (Q wave and non-Q wave), or coronary revascularization (i.e. coronary artery bypass surgery or percutaneous coronary intervention) at discharge, 6 months and 12 months post surgery [ Time Frame: 12 months ]
  2. Per-patient incidence of vein graft failure/occlusion [ Time Frame: 12 months ]
  3. Per-graft incidence of vein graft failure/occlusion [ Time Frame: 12 months ]
  4. Rates of graft failure due to characterization of anastomotic site failure vs. graft failure [ Time Frame: 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. require on-pump SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic coronary artery disease, with ≥ 75% stenosis in each of these vessels
  2. have appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and a lack of calcification at the anastomotic site
  3. are able to give their informed written consent
  4. are ≥ 21 years of age

Exclusion Criteria:

  1. no appropriate target coronary vessel
  2. discreet attachment of each SVG to the aorta is not possible (non-consecutive or "jump" grafts are excluded)
  3. concomitant non-CABG cardiac procedure
  4. prior peripheral vascular or cardiac surgery
  5. prior stroke
  6. history of atrial fibrillation
  7. diffuse peripheral vascular disease
  8. age > 80
  9. LVEF < 30% at time of enrollment
  10. Insulin-dependent diabetes
  11. concurrent participation in another trial
  12. concomitant life-threatening disease likely to limit life expectancy to less than 2 years
  13. contra-indications to on-pump CABG with cardioplegic arrest (calcified aorta, calcified coronaries, small target vessels)
  14. emergency CABG surgery
  15. inability to tolerate or comply with normal post-surgical drug regimen (antiplatelet plus statin)
  16. taking warfarin or clopidogrel at the time of surgery
  17. inability to comply with required follow-ups, including angiography imaging methods
  18. patient is pregnant or intends on becoming pregnant in the next 12 months
Contacts and Locations
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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): NCT00777777


Contacts
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Contact: Uwe Klima, MD, PhD 00656772 ext 2065 uwe_klima@nuh.com.sg
Contact: Theodoros Kofidis, MD, PhD 00656772 ext 2076 surtk@nus.edu.sg

Locations
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Singapore
Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore Recruiting
Singapore, Singapore, 119074
Contact: Uwe Klima, MD, PhD    00656772 ext 2065    uwe_klima@nuh.com.sg   
Sponsors and Collaborators
National University Hospital, Singapore
Kips Bay Medical, Inc.
Transmedic Pte Ltd, Singapore
Investigators
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Principal Investigator: Uwe Klima, MD, PhD Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore
More Information
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Publications:

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Responsible Party: Uwe Klima, MD, PhD, National University Hospital Singapore
ClinicalTrials.gov Identifier: NCT00777777    
Other Study ID Numbers: DSRB-C/08/149
First Posted: October 22, 2008    Key Record Dates
Last Update Posted: October 22, 2008
Last Verified: October 2008
Keywords provided by National University Hospital, Singapore:
multi-vessel, therapy, surgery, CABG
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases