Meshed Vein Graft Patency Trial - VEST

NCT ID: NCT01860274

Last Updated: 2021-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-06

Study Completion Date

2020-06-28

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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External Mesh

Group Type EXPERIMENTAL

External Mesh for vein grafts

Intervention Type DEVICE

Interventions

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External Mesh for vein grafts

Intervention Type DEVICE

Eligibility Criteria

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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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiochirurgia E.H.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca Weltert, MD

Role: PRINCIPAL_INVESTIGATOR

European Hospital - Rome

Ruggero De Paulis, MD

Role: STUDY_CHAIR

European Hospital - Rome

Locations

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European Hospital

Rome, , Italy

Site Status

Mauriziano Hospital

Turin, , Italy

Site Status

Countries

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Italy

References

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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.

Reference Type DERIVED
PMID: 33845865 (View on PubMed)

Other Identifiers

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00-06

Identifier Type: -

Identifier Source: org_study_id

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