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NCT01415245 Clinical Trial

Vein External Support Trial

Coronary Heart Disease Clinical Trial

— VEST  

Official title:
Vein External Support Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01415245
Other study ID # CI-01-01
Secondary ID
Status Completed
Phase N/A
First received August 10, 2011
Last updated May 18, 2014
Start date October 2011
Est. completion date December 2013

Study information
Verified date May 2014
Source Vascular Graft Solutions Ltd.
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2013
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender Both
Age group 50 Years to 80 Years
Eligibility Primary Inclusion Criteria:

1. Patient scheduled for on-pump CABG on clinical grounds

2. Vein grafts indicated for right and circumflex coronary arteries and LIMA indicated for the LAD on clinical grounds

3. Native circumflex and right coronary arteries have at least one stenosis in each vessel> 75%

Primary Exclusion Criteria:

1. Concomitant non-CABG cardiac procedure

2. Prior peripheral vascular or cardiac surgery

3. Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Fluent (VGS Fluent external support device)
Fluent external support device applied to saphenous vein graft

Locations
Country Name City State
United Kingdom Royal Brompton Hospital London
United Kingdom Harefield Hospital Middlesex
United Kingdom The John Radcliffe Hospital Oxford

Sponsors (1)
Lead Sponsor Collaborator
Vascular Graft Solutions Ltd.

Country where clinical trial is conducted

United Kingdom, 

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