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NCT01860274 Clinical Trial

Meshed Vein Graft Patency Trial - VEST

Coronary Artery Disease Clinical Trial

Official title:
External Mesh of Vein Grafts In Coronary Artery Bypass Grating: Early Patency and Clinical Outcome

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01860274
Other study ID # 00-06
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 6, 2015
Est. completion date June 28, 2020

Study information
Verified date March 2021
Source Cardiochirurgia E.H.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date June 28, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• External Mesh for vein grafts

Locations
Country Name City State
Italy European Hospital Rome
Italy Mauriziano Hospital Turin

Sponsors (1)
Lead Sponsor Collaborator
Cardiochirurgia E.H.

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patency Patency of graft at CT Scan 6 to 12 months
Secondary Major Adverse Cardiac and Cerebrovascular Events (MACCE) 60 months
Secondary Vein graft lumen uniformity 6 to 12 months
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