Vein External Support Trial (VEST)
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fluent (VGS Fluent external support device)
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Heart Disease
Eligibility Criteria
Primary Inclusion Criteria:
- Patient scheduled for on-pump CABG on clinical grounds
- Vein grafts indicated for right and circumflex coronary arteries and LIMA indicated for the LAD on clinical grounds
- Native circumflex and right coronary arteries have at least one stenosis in each vessel> 75%
Primary Exclusion Criteria:
- Concomitant non-CABG cardiac procedure
- Prior peripheral vascular or cardiac surgery
- Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)
Sites / Locations
- Royal Brompton Hospital
- Harefield Hospital
- The John Radcliffe Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment
Control
Arm Description
Device applied to saphenous vein graft
Saphenous vein graft without device support
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01415245
First Posted
August 10, 2011
Last Updated
May 18, 2014
Sponsor
Vascular Graft Solutions Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01415245
Brief Title
Vein External Support Trial
Acronym
VEST
Official Title
Vein External Support Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vascular Graft Solutions Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Device applied to saphenous vein graft
Arm Title
Control
Arm Type
No Intervention
Arm Description
Saphenous vein graft without device support
Intervention Type
Device
Intervention Name(s)
Fluent (VGS Fluent external support device)
Intervention Description
Fluent external support device applied to saphenous vein graft
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Inclusion Criteria:
Patient scheduled for on-pump CABG on clinical grounds
Vein grafts indicated for right and circumflex coronary arteries and LIMA indicated for the LAD on clinical grounds
Native circumflex and right coronary arteries have at least one stenosis in each vessel> 75%
Primary Exclusion Criteria:
Concomitant non-CABG cardiac procedure
Prior peripheral vascular or cardiac surgery
Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)
Facility Information:
Facility Name
Royal Brompton Hospital
City
London
Country
United Kingdom
Facility Name
Harefield Hospital
City
Middlesex
Country
United Kingdom
Facility Name
The John Radcliffe Hospital
City
Oxford
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
30453984
Citation
Taggart DP, Webb CM, Desouza A, Yadav R, Channon KM, De Robertis F, Di Mario C. Long-term performance of an external stent for saphenous vein grafts: the VEST IV trial. J Cardiothorac Surg. 2018 Nov 19;13(1):117. doi: 10.1186/s13019-018-0803-9.
Results Reference
derived
Learn more about this trial
Vein External Support Trial
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