VEST™ III PMS clinical protocol
Research type
Research Study
Full title
VEST™ III PMS clinical protocol
IRAS ID
181166
Contact name
Orit Yarden
Contact email
Sponsor organisation
Vascular Graft Solutions Ltd.
Duration of Study in the UK
2 years, 6 months, 1 days
Research summary
Coronary Artery Bypass Grafting (CABG) remains the gold standard treatment for patients suffering from multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. However, progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.
Three landmark studies have quantified, by angiography, both occlusion and disease progression in SVGs up to 25 years post CABG. According to these studies, around 20-25% of SVGs occlude over the first year and approximately 35%-40% by five years. SVG disease progresses over time even in patent grafts from 10% at 6 months8 to as many as 50% at five years. SVG failure increases the risk for recurrent myocardial infarction and the need for repeat intervention.
The VGS VEST is a novel external support system which was developed for cardiac surgeons. It is a unique, surgeon-friendly, kink resistant and fully-adjustable stent, which does not present any interference to the normal conduct of the CABG procedure.
The device provides the vein with radial support and arterial-like biomechanical properties, reduces its wall tension, and increases the vein uniformity and improves its flow pattern. The device prevents the vein graft non-uniform dilation and distortion (which leads to turbulent blood flow and thrombus formation).The purpose of this study is to enhance the clinical data available for the VEST in bypass grafts and obtain robust long term data. 200 patients will be enrolled and their health status will be checked at regular time intervals (6 weeks, 6 months, 1 year and 2 years).
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0311
Date of REC Opinion
9 Jul 2015
REC opinion
Further Information Favourable Opinion