NCT04761068

Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts

Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery With VEST Supported Venous Grafts

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Cardiocentro Ticino · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This is a prospective, investigator-initiated, multi-center, open label and post-market registry, enrolling patients with atherosclerotic coronary artery disease, scheduled for CABG with at least one SVG bypass. The registry is designed to evaluate the clinical outcome of CABG surgery with an external support device (VEST) for SVG bypasses. In each patient, use of the VEST will be according to its approved indications for use and attempt will be made (based on clinical judgement) to support each non-sequential SVG bypass graft with a VEST device. Subjects will be followed for 5 years, with interim follow ups at 12 and 24 months. MACCE and EQ5D3L will be documented at every follow up visit.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	VEST	Venous External Support for vein grafts in CABG

Timeline

• Start date: 2017-12-15
• Primary completion: 2026-03-30
• Completion: 2026-03-30
• First posted: 2021-02-18
• Last updated: 2021-02-18

Locations

13 sites across 5 countries: Austria, Germany, Italy, Spain, Switzerland