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
-
-
-
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
|
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
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.
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
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.