Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory

NCT ID: NCT06877195

Last Updated: 2025-03-18

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

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2028-05-01

Brief Summary

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Multicentre randomised prospective study aimed at verifying medium-term patency of venous grafts on the right coronary artery territory, by clinical and/or instrumental follow-up with particular attention to clinically driven re-revascularisation events regarding the site of new lesions (granularly comparing sites already treated with VEST, sites treated with bare vein, sites treated with other conduits, de novo lesions on the native).

Detailed Description

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Conditions

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Ischemic Cardiovascular Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vested vein

Usage of External mesh support (VEST) around the venous graft

Group Type EXPERIMENTAL

CABG

Intervention Type PROCEDURE

Aortocoronary bypass procedures with venous grafts on right coronary territory

Unvested vein

Normally harvested and preserved "naked" vein used as a graft

Group Type ACTIVE_COMPARATOR

CABG

Intervention Type PROCEDURE

Aortocoronary bypass procedures with venous grafts on right coronary territory

Interventions

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CABG

Aortocoronary bypass procedures with venous grafts on right coronary territory

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* combined or isolated interventions
* adequate vein calibre
* adequate graft flowmetry

Exclusion Criteria

* inability to implant due to calibre disparity or inadequate flowmetry
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 Paolo Weltert, MD

Role: PRINCIPAL_INVESTIGATOR

Unicamillus

Locations

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European Hospital

Roma, Roma, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Luca Paolo Weltert, MD

Role: CONTACT

+393478880617

Facility Contacts

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Luca Paolo Weltert, MD

Role: primary

+393478880617

Other Identifiers

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MCRiVEST-1

Identifier Type: -

Identifier Source: org_study_id

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