Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts
NCT ID: NCT04761068
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2017-12-15
2026-03-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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VEST
Venous External Support for vein grafts in CABG
Eligibility Criteria
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Inclusion Criteria
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
2. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
18 Years
ALL
No
Sponsors
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Cardiocentro Ticino
OTHER
Responsible Party
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Stefanos Demertzis
Head of cardiac surgery
Principal Investigators
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Stefanos Demertzis
Role: PRINCIPAL_INVESTIGATOR
Cardiocentro Ticino
Locations
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Medical University of Innsbruck
Innsbruck, , Austria
AKH (Vienna General Hospital)
Vienna, , Austria
Floridsdorf Clinic
Vienna, , Austria
Herzzentrum Dresden
Dresden, , Germany
Klinikum Nürnberg
Nuremberg, , Germany
Krankenhaus der Barmherzigen Brüder
Trier, , Germany
European hospital
Roma, , Italy
Mauriziano Hospital
Turin, , Italy
Germans Trias i Pujol
Badalona, , Spain
University hospital of the Canary Islands
Santa Cruz de Tenerife, , Spain
Ribera hospital
Valencia, , Spain
Cardiocentro Ticino
Lugano, , Switzerland
Triemli University Hospital
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Stefanos Demertzis, Professor
Role: primary
Other Identifiers
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VEST registry
Identifier Type: -
Identifier Source: org_study_id
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