Meshed Vein Graft Patency Trial - VEST

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: External Mesh for vein grafts

• Registration Number: NCT01860274
• Lead Sponsor: Cardiochirurgia E.H.

Brief Summary

The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone.

To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-21
• Study First Posted: 2013-05-22
• Study Start: 2015-09-06
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-28
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-10
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
• Coronary artery with critical stenosis (over 70%)

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
External Mesh	External Mesh for vein grafts	-

Primary Outcome Measures

Name	Time	Method
Patency	6 to 12 months	Patency of graft at CT Scan

Secondary Outcome Measures

Name	Time	Method
Major Adverse Cardiac and Cerebrovascular Events (MACCE)	60 months
Vein graft lumen uniformity	6 to 12 months

Trial Locations

Locations (2)

European Hospital; 🇮🇹 Rome, Italy

Mauriziano Hospital; 🇮🇹 Turin, Italy