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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VEST | Device | Venous External Support for vein grafts in CABG |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stefanos Demertzis, Professor | Contact | +41918053147 | Stefanos.Demertzis@cardiocentro.org |
| Name | Affiliation | Role |
|---|---|---|
| Stefanos Demertzis | Cardiocentro Ticino | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Innsbruck | Recruiting | Innsbruck | Austria |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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 |
| AKH (Vienna General Hospital) | Recruiting | Vienna | Austria |
|
| Floridsdorf Clinic | Recruiting | Vienna | Austria |
|
| Herzzentrum Dresden | Terminated | Dresden | Germany |
| Klinikum Nürnberg | Recruiting | Nuremberg | Germany |
|
| Krankenhaus der Barmherzigen Brüder | Recruiting | Trier | Germany |
|
| European hospital | Recruiting | Roma | Italy |
|
| Mauriziano Hospital | Recruiting | Turin | Italy |
|
| Germans Trias i Pujol | Recruiting | Badalona | Spain |
|
| University hospital of the Canary Islands | Recruiting | Santa Cruz de Tenerife | Spain |
|
| Ribera hospital | Recruiting | Valencia | Spain |
|
| Cardiocentro Ticino | Recruiting | Lugano | Switzerland |
|
| Triemli University Hospital | Recruiting | Zurich | Switzerland |
|
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |