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

March 14, 2025 updated by: Cardiochirurgia E.H.

Multicenter Randomised Prospective Study for External Support Mesh VEST of Venous Coronary Grafts on the Right Territory: Mid-term Clinically Driven Re-rivascularization Events Comparison Between Sites Treated with VEST, Sites Treated with Bare Vein, Sites Treated with Other Conduits and De Novo Lesions on the Native Vessels

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact

Study Locations

  • Italy
      • Roma, Italy, 00149
        • Recruiting
        • European Hospital
        • Contact:
        • Contact:
          • Luca Paolo Weltert, MD

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • inability to implant due to calibre disparity or inadequate flowmetry

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vested vein
Usage of External mesh support (VEST) around the venous graft
Procedure: CABG
Aortocoronary bypass procedures with venous grafts on right coronary territory
Active Comparator: Unvested vein
Normally harvested and preserved "naked" vein used as a graft
Procedure: CABG
Aortocoronary bypass procedures with venous grafts on right coronary territory

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ri-revascularization of grafted territory
Time Frame: Till end of study (at least three years)
Incidence of coronary ri-revascaularization by either angioplasty or surgical bypass concerning the grafted territory due to graft failure
Till end of study (at least three years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: Till end of study (at least three years)
Incidence of Major Cardiovascular and Cerebrovascular Events
Till end of study (at least three years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiochirurgia E.H.

Investigators

  • Principal Investigator: Luca Paolo Weltert, MD, Unicamillus

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)

March 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 10, 2025

First Submitted That Met QC Criteria

March 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCRiVEST-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonimized clinical parameters

IPD Sharing Time Frame

Form start to end of study

IPD Sharing Access Criteria

Centers collaborating to active recruitment, to be added after the completion of their each institutional review

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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.

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