NCT01415245

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

1.9 years

First QC Date

August 10, 2011

Last Update Submit

May 18, 2014

Conditions

Coronary Heart Disease

Study Arms (2)

Treatment

EXPERIMENTAL

Device applied to saphenous vein graft

Device: Fluent (VGS Fluent external support device)

Control

NO INTERVENTION

Saphenous vein graft without device support

Interventions

Fluent (VGS Fluent external support device)DEVICE

Fluent external support device applied to saphenous vein graft

Treatment

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Concomitant non-CABG cardiac procedure
  • Prior peripheral vascular or cardiac surgery
  • Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Royal Brompton Hospital

London, United Kingdom

Location

Harefield Hospital

Middlesex, United Kingdom

Location

The John Radcliffe Hospital

Oxford, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 30453984DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 11, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

GB(3)