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
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Device: eSVS, saphenous vein supporting mesh||Phase 2|
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:
- SVG+eSVS™ Mesh at Right Coronary Artery and SVG at Circumflex Artery or
- 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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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 ]
- 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 ]
- 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 ]
- Per-patient incidence of vein graft failure/occlusion [ Time Frame: 12 months ]
- Per-graft incidence of vein graft failure/occlusion [ Time Frame: 12 months ]
- Rates of graft failure due to characterization of anastomotic site failure vs. graft failure [ Time Frame: 12 months ]
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
|Contact: Uwe Klima, MD, PhD||00656772 ext firstname.lastname@example.org|
|Contact: Theodoros Kofidis, MD, PhD||00656772 ext email@example.com|
|Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Uwe Klima, MD, PhD 00656772 ext 2065 firstname.lastname@example.org|
|Principal Investigator:||Uwe Klima, MD, PhD||Department of Cardiac, Thoracic and Vascular Surgery, National University Hospital Singapore|