Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts
NCT04761068 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000
Last updated 2021-02-18
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
Interventions
- DEVICE
-
VEST
Venous External Support for vein grafts in CABG
Sponsors & Collaborators
-
Cardiocentro Ticino
lead OTHER
Principal Investigators
-
Stefanos Demertzis · Cardiocentro Ticino
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-12-15
- Primary Completion
- 2026-03-30
- Completion
- 2026-03-30
Countries
- Austria
- Germany
- Italy
- Spain
- Switzerland
Study Locations
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