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

Study Overview
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Brief Summary
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: VEST


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: VEST|Venous External Support for vein grafts in CABG|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic driven target vessel revascularization | CABG or PCI of VEST supported vein graft or associated target coronary artery | 5 years post Index CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACCE | 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). | 1, 2, and 5 years post index CABG | 
| Myocardial Infarction (MI) | Myocardial Infarction (MI) | 1, 2, and 5 years post index CABG | 
| Recurrent revascularization | Recurrent revascularization | 1, 2, and 5 years post index CABG | 
| Survival | Survival, both overall and freedom from cardiac death | 1, 2, and 5 years post index CABG | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary artery bypass surgery, CABG, External support