Back to resultsMeshed Vein Graft Patency Trial - VEST
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
External Mesh for vein grafts
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Mesh, Graft, Patency
Eligibility Criteria
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:
-
Sites / Locations
- European Hospital
- Mauriziano Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
External Mesh
Arm Description
Outcomes
Primary Outcome Measures
Patency
Patency of graft at CT Scan
Secondary Outcome Measures
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Vein graft lumen uniformity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01860274
Brief Title
Meshed Vein Graft Patency Trial - VEST
Official Title
External Mesh of Vein Grafts In Coronary Artery Bypass Grating: Early Patency and Clinical Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 6, 2015 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
June 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardiochirurgia E.H.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Mesh, Graft, Patency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
External Mesh
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
External Mesh for vein grafts
Primary Outcome Measure Information:
Title
Patency
Description
Patency of graft at CT Scan
Time Frame
6 to 12 months
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time Frame
60 months
Title
Vein graft lumen uniformity
Time Frame
6 to 12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luca Weltert, MD
Organizational Affiliation
European Hospital - Rome
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ruggero De Paulis, MD
Organizational Affiliation
European Hospital - Rome
Official's Role
Study Chair
Facility Information:
Facility Name
European Hospital
City
Rome
ZIP/Postal Code
00149
Country
Italy
Facility Name
Mauriziano Hospital
City
Turin
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
33845865
Citation
Weltert LP, Audisio K, Bellisaro A, Bardi G, Flocco R, De Paulis R, Centofanti P. External stenting of vein grafts in coronary artery bypass grating: interim results from a two centers prospective study. J Cardiothorac Surg. 2021 Apr 12;16(1):74. doi: 10.1186/s13019-021-01406-0.
Results Reference
derived
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Meshed Vein Graft Patency Trial - VEST
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