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CompletedNCT01860274Updated Mar 12, 2021

Meshed Vein Graft Patency Trial - VEST

An interventional study of External Mesh for vein grafts in Coronary Artery Disease, sponsored by Cardiochirurgia E.H.. Completed at 2 sites in Italy. Per ClinicalTrials.gov, last updated 2021-03-12.

Sponsored by Cardiochirurgia E.H. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Not applicable
Sex
All
01

Study 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.

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Conditions studied

  • Coronary Artery Disease

Keywords

  • Mesh
  • Graft
  • Patency
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In context

Coronary Artery Disease

5,596 studies on the registry are indexed under Coronary Artery Disease; 955 are open to participants now.

This study's enrollment of 102 is below the median of 123 across 3,435 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Cardiochirurgia E.H. is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
102 participants (actual)

Study arms

  • Experimental
    External Mesh

    Device: External Mesh for vein grafts

Interventions

  • DeviceExternal Mesh for vein grafts
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What researchers measure

Primary outcomes

  1. Patency

    Patency of graft at CT Scan

    Time frame: 6 to 12 months

Secondary outcomes

  1. Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    Time frame: 60 months

  2. Vein graft lumen uniformity

    Time frame: 6 to 12 months

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Study locations

2 sites
  • European Hospital
    Rome, 00149, Italy
  • Mauriziano Hospital
    Turin, Italy
08

References and documents

Publications

  • 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. PubMed 33845865 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01860274
Lead sponsor
Cardiochirurgia E.H.
Responsible party
Sponsor
First posted
May 22, 2013
Start date
Sep 6, 2015
Primary completion
Dec 31, 2019
Completion
Jun 28, 2020
Last update
Mar 12, 2021

Study contacts

Luca Weltert, MD
principal investigator · European Hospital - Rome
Ruggero De Paulis, MD
study chair · European Hospital - Rome

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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