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

Cardiocentro Ticino1,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

1,000

Conditions

Coronary Artery Disease

Interventions

VESTDEVICE

Venous External Support for vein grafts in CABG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (13)

Medical University of Innsbruck

Innsbruck, Austria

RECRUITING

AKH (Vienna General Hospital)

Vienna, Austria

RECRUITING

Floridsdorf Clinic

Vienna, Austria

RECRUITING

Herzzentrum Dresden

Dresden, Germany

TERMINATED

Klinikum Nürnberg

Nuremberg, Germany

RECRUITING

Krankenhaus der Barmherzigen Brüder

Trier, Germany

RECRUITING

European hospital

Roma, Italy

RECRUITING

Mauriziano Hospital

Turin, Italy

RECRUITING

Germans Trias i Pujol

Badalona, Spain

RECRUITING

University hospital of the Canary Islands

Santa Cruz de Tenerife, Spain

RECRUITING

...and 3 more locations

Outcomes

Primary Outcomes

Ischemic driven target vessel revascularization

CABG or PCI of VEST supported vein graft or associated target coronary artery

Time frame: 5 years post Index CABG

Secondary Outcomes

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).

Time frame: 1, 2, and 5 years post index CABG

Myocardial Infarction (MI)

Time frame: 1, 2, and 5 years post index CABG

Recurrent revascularization

Time frame: 1, 2, and 5 years post index CABG

Survival

Survival, both overall and freedom from cardiac death

Time frame: 1, 2, and 5 years post index CABG

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

Overview

Conditions

Interventions

Eligibility

Locations (13)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts