Status:
COMPLETED
Vein External Support Trial
Lead Sponsor:
Vascular Graft Solutions Ltd.
Conditions:
Coronary Heart Disease
Eligibility:
All Genders
50-80 years
Phase:
NA
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 c...
Eligibility Criteria
Inclusion
- Primary
- 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
- Concomitant non-CABG cardiac procedure
- Prior peripheral vascular or cardiac surgery
- Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01415245
Start Date
October 1 2011
End Date
December 1 2013
Last Update
May 20 2014
Active Locations (3)
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1
Royal Brompton Hospital
London, United Kingdom
2
Harefield Hospital
Middlesex, United Kingdom
3
The John Radcliffe Hospital
Oxford, United Kingdom