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

ConditionIschemic Cardiovascular Disease

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorCardiochirurgia E.H.

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

combined or isolated interventions

adequate vein calibre

adequate graft flowmetry

Disqualifiers

inability to implant due to calibre disparity or inadequate flowmetry

Trial design

Design model

Parallel

Treatments tested in this trial

CABG
Procedure/Surgery
Aortocoronary bypass procedures with venous grafts on right coronary territory

Treatment groups

300 Participants

are divided into 2 treatment groups

Group A: Vested veinExperimental treatment 1 intervention

Group B: Unvested veinActive comparator 1 intervention

Trial outcomes

Primary outcomes

Ri-revascularization of grafted territory

Incidence of coronary ri-revascaularization by either angioplasty or surgical bypass concerning the grafted territory due to graft failure

Time frame

Till end of study (at least three years)

Secondary outcomes

Major Cardiovascular and Cerebrovascular Events (MACCE)

Incidence of Major Cardiovascular and Cerebrovascular Events

Time frame

Till end of study (at least three years)

Sponsors and contacts

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Cardiochirurgia E.H.

Lead sponsor

Source ClinicalTrials.gov

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