Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery With VEST Supported Venous Grafts
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 1,000
- Locations
- 13
- Primary Endpoint
- Ischemic driven target vessel revascularization
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment.
- •Saphenous vein graft length and diameter are adequate for the planned intervention.
- •Patient is willing and able to give their written informed consent to participate in the registry study.
- •Patient is over 18 years of age
Exclusion Criteria
- •Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP)
- •Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Outcomes
Primary Outcomes
Ischemic driven target vessel revascularization
Time Frame: 5 years post Index CABG
CABG or PCI of VEST supported vein graft or associated target coronary artery
Secondary Outcomes
- Myocardial Infarction (MI)(1, 2, and 5 years post index CABG)
- Survival(1, 2, and 5 years post index CABG)
- MACCE(1, 2, and 5 years post index CABG)
- Recurrent revascularization(1, 2, and 5 years post index CABG)
Investigators
Stefanos Demertzis
Head of cardiac surgery
Cardiocentro Ticino