VEST II
A prospective study of external stenting of saphenous vein grafts to the right coronary artery: the VEST II study
Study design & primary objectives
NCT02332330 (clinicaltrials.gov reference #)
Trial period: Jan 2015 - Oct 2015
Sample size: N = 30
Participating center:
John Radcliffe, Oxford, UK
Principal investigator:
Prof. David Taggart, Oxford, UK.
Design:
A prospective post-marketing single-arm study, designed to test the early-midterm patency rate of VEST supported SVG’s to the Right Coronary Artery (RCA).
According to lessons learned from a pre-marketing clinical trial (VEST I), strict procedures were followed regarding the exclusive use of sutures to ligate side branches and VEST placement with no fixation to the tissue.
Primary Objective:
Analysis of early vein graft patency as assessed by CT-angiography at 3-6M.
Results summary
Patency Rate:
The patency rate of the VEST supported SVGs to the RCA was 86.3% at 3-6 months post CABG (single-arm trial, no control) compared to 54.8% in the VEST I trial.
Comment: unlike the first in human (VEST I) trial, this trial mandated that metallic clips were not to be used to ligate SVG side branches.
Historical Data regarding early patency rates of SVGs to the right coronary territory report early patency between 71% to 86%
Main Conclusions
1. Avoiding the use of metal ligation clips for SVG side branches significantly improves VEST supported SVG patency to the right coronary territory.
2. Early patency of VEST supported SVG is comparable and on the upper level of patency rates reported for right coronary grafts
VEST II Publications
Name |
Link |
A prospective study of external stenting of saphenous vein grafts to the right coronary artery: the VEST II study |