VEST Device to Enhance Safein Vein Patency

Completed

• Conditions: Coronary Artery Bypass

• Registration Number: NCT06500897
• Lead Sponsor: Cardiochirurgia E.H.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-02
• Primary Completion: 2024-06-30
• Status Verified: 2024-07
• Study Completion: 2024-07-08
• Study First Submitted: 2024-07-08
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-13
• Study First Posted: 2024-07-15
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

• CABG with at least one VEST implant

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Re-rivascularization	Up to 7 years	Number of PCI or re-CABG performed, stratified by target site
MACCE	Up to 7 years	Major adverse cardiac and cerebrovascular events

Trial Locations

Locations (3)

Medical University of Vienna; 🇦🇹 Vienna, Austria

Cardiochirurgia European Hospital; 🇮🇹 Rome, Italy

Mauriziano Hospital; 🇮🇹 Turin, Italy