Meshed Vein Graft Patency Trial - VEST

March 10, 2021 updated by: Cardiochirurgia E.H.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00149
        • European Hospital
      • Turin, Italy
        • Mauriziano Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: External Mesh
Device: External Mesh for vein grafts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patency
Time Frame: 6 to 12 months
Patency of graft at CT Scan
6 to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame: 60 months
60 months
Vein graft lumen uniformity
Time Frame: 6 to 12 months
6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiochirurgia E.H.

Investigators

  • Principal Investigator: Luca Weltert, MD, European Hospital - Rome
  • Study Chair: Ruggero De Paulis, MD, European Hospital - Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2015

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

June 28, 2020

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 21, 2013

First Posted (Estimate)

May 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 12, 2021

Last Update Submitted That Met QC Criteria

March 10, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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