NCT06877195

Brief Summary

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
25mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Mar 2025May 2028

Study Start

First participant enrolled

March 1, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 10, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 18, 2025

Status Verified

March 1, 2025

Enrollment Period

3 years

First QC Date

March 10, 2025

Last Update Submit

March 14, 2025

Conditions

Ischemic Cardiovascular Disease

Keywords

Coronary Artery Bypass Graft

Outcome Measures

Primary Outcomes (1)

  • Ri-revascularization of grafted territory

    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 Outcomes (1)

  • Major Cardiovascular and Cerebrovascular Events (MACCE)

    Till end of study (at least three years)

Study Arms (2)

Vested vein

EXPERIMENTAL

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

Procedure: CABG

Unvested vein

ACTIVE COMPARATOR

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

Procedure: CABG

Interventions

CABGPROCEDURE

Aortocoronary bypass procedures with venous grafts on right coronary territory

Unvested veinVested vein

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • inability to implant due to calibre disparity or inadequate flowmetry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Hospital

Roma, Roma, 00149, Italy

RECRUITING

Study Officials

  • Luca Paolo Weltert, MD

    Unicamillus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Paolo Weltert, MD

CONTACT

+393478880617lweltert@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2025

First Posted

March 14, 2025

Study Start

March 1, 2025

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

May 1, 2028

Last Updated

March 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Anonimized clinical parameters

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Form start to end of study
Access Criteria
Centers collaborating to active recruitment, to be added after the completion of their each institutional review

Locations

IT(1)