Vein External Support Trial

Not Applicable

Completed

• Conditions: Coronary Heart Disease
• Interventions: Device: Fluent (VGS Fluent external support device)

• Registration Number: NCT01415245
• Lead Sponsor: Vascular Graft Solutions Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-11
• Study Start: 2011-10
• Primary Completion: 2013-09
• Study Completion: 2013-12
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-18
• Last Update Posted: 2014-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Fluent (VGS Fluent external support device)	Device applied to saphenous vein graft

Trial Locations

Locations (3)

Harefield Hospital; 🇬🇧 Middlesex, United Kingdom

The John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Royal Brompton Hospital; 🇬🇧 London, United Kingdom