The eMESH I Feasibility Study
Research type
Research Study
Full title
A multi-center, randomized study of external saphenous vein support using eSVS Mesh in CABG Surgery:The eMESH I Study
IRAS ID
131959
Contact name
Anthony DeSouza
Contact email
Sponsor organisation
Kips Bay Medical, Inc.
Research summary
Coronary arteries are the small blood vessels that supply the heart with oxygen and nutrients. When one or more of the coronary arteries becomes partially or totally blocked, the heart does not get an adequate blood supply. This is called coronary artery disease (CAD). Heart bypass surgery (Coronary Artery Bypass Graft, or CABG) creates a detour or "bypass" around the blocked part of a coronary artery to restore the blood supply to the heart muscle. A vein from the inside of the leg, called the saphenous vein, is commonly used for the bypass, and is called a saphenous vein graft (SVG).
Saphenous vein grafts (SVG’s) used in CABG surgery become blocked, as often as 30% of the time in the first year after implant. This blockage is largely due to the increased pressure on the SVG when it is placed on the heart. This increased pressure can cause the SVG to expand, leading to thickening of the wall of the SVG and ultimately its complete blockage.
This study aims to study a novel product named the eSVS Mesh. The device is an External Saphenous Vein Support device, designed to provide external support for a saphenous vein graft during coronary artery bypass grafting, in order to provide additional strength to the SVG. The eSVS Mesh is made of a flexible metal wire, knitted into a cylindrical shape (like a sock). In this trial, one of the bypass SVGs will receive the eSVS Mesh, and one of the bypass SVGs will not. Patients will be followed up at 30 days, 3 months, 6 months and one year and yearly thereafter for 5 years. Coronary angiography will be performed at 6 months. The aim of the study is to determine safety and efficacy of the eSVS Mesh up to 5 years after being implanted.REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1010
Date of REC Opinion
13 Sep 2013
REC opinion
Further Information Favourable Opinion