NCT00777777

The eSVS (TM) Mesh External Saphenous Vein Support Trial

The eSVS(TM)Mesh External Saphenous Vein Support Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: National University Hospital, Singapore · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-06-01
• Completion: 2009-09-01
• First posted: 2008-10-22
• Last updated: 2008-10-22

Locations

1 site across 1 country: Singapore