CD0104 VEST II Post Marketing Surveillance Study
Research type
Research Study
Full title
A post-market prospective study of the VGS VEST (Venous External Support), supporting saphenous vein grafts for coronary bypass graft surgery in patients with severe coronary heart disease
IRAS ID
162258
Contact name
David T Taggart
Contact email
Research summary
Pre-market clinical data from a multicenter randomized controlled study in the UK demonstrated excellent device safety and no device related adverse events, along with a significant reduction in vein graft disease (intimal hyperplasia) in the supported grafts. In addition, the supported grafts demonstrated improved lumen uniformity and minimal incidence of segmental dilatation (ectasia) compared to the unsupported grafts.
The clinical data has shown that VEST had a better effectiveness in inhibiting intimal hyperplasia in supported vein grafts to the right coronary territory (RCA bypass) than in those to the left territory 1 year after CABG. However, supported vein grafts to the right territory also had higher failure rates than those of the supported vein grafts to the left territory. This is attributed to several issues:
(1) The use of metal clips (instead of ties) to ligate side branches which deformed the lumen when covered by the device
(2) The occurrence of protocol deviation where the device was sutured to the anastomoses in several cases
(3) The curved geometry of vein grafts to the RCA that makes it more vulnerable to both fixation of the anastomosis with sutures and distortion by metal clips.
Another limitation of the prior clinical data is the lack of precise timing of early graft failure data. 1 year follow up data was available and proved the long term positive effect of VEST on vein graft biology (mitigation of intimal hyperplasia) but it was not possible to conclude which failures of the supported and unsupported grafts was early after CABG and predominantly due to technical errors.In this context it is now desired to test the VEST in RCA bypass grafts, when only sutures will be used to ligate side branches, no attachment/fixation of the device to the anastomosis will be performed, and patency data will be obtained in the short-mid term.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
14/EE/1106
Date of REC Opinion
24 Sep 2014
REC opinion
Unfavourable Opinion