Vein External Support Trial (VEST)

Vascular Graft Solutions

Status: Completed

Conditions: Coronary Heart Disease

Treatments: Device: Fluent (VGS Fluent external support device)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01415245

CI-01-01

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Treatment

Experimental group

Description:

Device applied to saphenous vein graft

Treatment:

Device: Fluent (VGS Fluent external support device)

Control

No Intervention group

Description:

Saphenous vein graft without device support