Vein External Support Trial

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.

Completed

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Brompton Hospital, London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fluent (VGS Fluent external support device)

Device

Fluent external support device applied to saphenous vein graft

Sponsors and collaborators

Lead sponsor

Vascular Graft Solutions Ltd.

Industry

Registry information

Acronym: VEST

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Aug 11, 2011
Registry last updated: May 20, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed