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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Page 1 of 1 (3 locations)

1

Royal Brompton Hospital

London, United Kingdom

2

Harefield Hospital

Middlesex, United Kingdom

3

The John Radcliffe Hospital

Oxford, United Kingdom