Coronary Artery Disease
Conditions
Keywords
Coronary artery bypass surgery, CABG, External support
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.
Interventions
DEVICEVEST
Venous External Support for vein grafts in CABG
Sponsors
Cardiocentro Ticino
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemic driven target vessel revascularization | 5 years post Index CABG | CABG or PCI of VEST supported vein graft or associated target coronary artery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Survival | 1, 2, and 5 years post index CABG | Survival, both overall and freedom from cardiac death |
| MACCE | 1, 2, and 5 years post index CABG | The occurrence of any of the following major adverse cardiac and cerebrovascular events (MACCE): death; Stroke; Myocardial infarction (MI) and Coronary revascularization (redo-CABG and PCI). |
| Myocardial Infarction (MI) | 1, 2, and 5 years post index CABG | Myocardial Infarction (MI) |
| Recurrent revascularization | 1, 2, and 5 years post index CABG | Recurrent revascularization |
Countries
Austria, Germany, Italy, Spain, Switzerland
Contacts
Primary ContactStefanos Demertzis, Professor
Outcome results
None listed