CD0378 VEST Extended Long Term Follow-Up Clinical Protocol
Research type
Research Study
Full title
VEST Extended Long term follow-up clinical protocol
IRAS ID
316249
Contact name
Peter Collins
Contact email
Sponsor organisation
Vascular Graft Solutions
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Coronary Artery Bypass Graft (CABG) provides excellent short and medium-term success but its long-term success may be limited by the failure of the veins that have been used to bypass the blood vessels of the heart.
Ten years after CABG around one-half of vein grafts have become blocked or diseased
The VEST is a delicate braided wire "sleeve", made of well-tested and widely used medical material, which is threaded over the bypass vein graft during the bypass operation.
Evidence from previous clinical use indicates that using the VEST on the vein graft assists in keeping this vein graft functional over time.
This is a follow-up study on patients who had the VEST implanted in the context of an earlier study (NCT01415245) (REF 11/EE/0177) and had one or more patent vein grafts at 4.5 years follow-up. Therefore, no VEST devices will be implanted during this current study. The aim of the study is to look at the long-term effect and the benefits of the VEST device on patients that underwent CABG more than 9 years ago and received a VEST device for one of the bypass vein grafts. Patients will undergo day-case CT angiography in order to assess the condition of the vein grafts, as will be interviewed for Major Adverse Cardiac Events and medication use.REC name
Wales REC 1
REC reference
23/WA/0064
Date of REC Opinion
9 Mar 2023
REC opinion
Favourable Opinion