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Clinical Trials/NCT06500897
NCT06500897
Completed
Not Applicable

Mid Term Follow up of VEST Device to Enhance Safein Vein Patency: a Multicentric Study

Cardiochirurgia E.H.3 sites in 2 countries385 target enrollmentJanuary 2, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Bypass
Sponsor
Cardiochirurgia E.H.
Enrollment
385
Locations
3
Primary Endpoint
Re-rivascularization
Status
Completed
Last Updated
last year

Overview

Brief Summary

Purpose - Bypass grafting is the gold standard for severe coronary disease, yet most repeat revascularizations target previously grafted territories. External stenting of saphenous vein grafts, the most frequently used bypass conduit, has been shown to minimize disease markers. This study evaluates clinical outcomes of external stenting in real world routine practice.

Methods - Three centers enrolled a prospective real-world cohort of external- stenting- enhanced CABG patients. All patients received an internal mammary artery graft to the left anterior descending artery and additional arterial and/or venous grafts. One or more venous grafts were externally stented. Choice of conduits, use of cardiopulmonary bypass, and vein harvesting technique were performed according to the routine practice of each surgeon.

All patients were prescribed standard of care medication and were followed via on site visits or phone interviews for major adverse myocardial and cerebral effects.

Registry
clinicaltrials.gov
Start Date
January 2, 2017
End Date
July 8, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Cardiochirurgia E.H.
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • CABG with at least one VEST implant

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Re-rivascularization

Time Frame: Up to 7 years

Number of PCI or re-CABG performed, stratified by target site

MACCE

Time Frame: Up to 7 years

Major adverse cardiac and cerebrovascular events

Study Sites (3)

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