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

Cardiocentro Ticino

Status: Enrolling

Conditions: Coronary Artery Disease

Treatments: Device: VEST

Study type: Observational

Funder types: Other

Identifiers

NCT04761068

VEST registry

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment.
2. Saphenous vein graft length and diameter are adequate for the planned intervention.
3. Patient is willing and able to give their written informed consent to participate in the registry study.
4. Patient is over 18 years of age

Exclusion criteria

1. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
2. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study