VEST™ Long term FU clinical protocol
Research type
Research Study
Full title
VEST™ Long term FU clinical protocol
IRAS ID
188108
Contact name
Orit Yarden
Contact email
Sponsor organisation
Vascular Graft Solutions Ltd.
Duration of Study in the UK
0 years, 8 months, 1 days
Research summary
Coronary Artery Bypass Grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease1. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. However, progressive SVG failure remains a key limitation to the long-term success of CABG.
This is a follow up study on patients who had the VEST implanted in the context of an earlier study. No VEST devices will be implanted during this current study. This current study is designed to bring back these patients, under certain eligibility criteria, for a long term follow up including angiography and IVUS, as well as MACE and medication.
The VGS VEST is an 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 lumen 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).In the current study it is desired to obtain long term data on disease progression in both VESTed and control vein grafts after a period of 3-4 years post CABG. This applies to those 27 patients which had one or more patent vein grafts at 12 months post CABG.
REC name
London - Bromley Research Ethics Committee
REC reference
15/LO/1862
Date of REC Opinion
2 Feb 2016
REC opinion
Further Information Favourable Opinion