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

NCT ID: NCT04761068

Last Updated: 2021-02-18

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-15

Study Completion Date

2026-03-30

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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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VEST

Venous External Support for vein grafts in CABG

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiocentro Ticino

OTHER

Sponsor Role lead

Responsible Party

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Stefanos Demertzis

Head of cardiac surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stefanos Demertzis

Role: PRINCIPAL_INVESTIGATOR

Cardiocentro Ticino

Locations

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Medical University of Innsbruck

Innsbruck, , Austria

Site Status RECRUITING

AKH (Vienna General Hospital)

Vienna, , Austria

Site Status RECRUITING

Floridsdorf Clinic

Vienna, , Austria

Site Status RECRUITING

Herzzentrum Dresden

Dresden, , Germany

Site Status TERMINATED

Klinikum Nürnberg

Nuremberg, , Germany

Site Status RECRUITING

Krankenhaus der Barmherzigen Brüder

Trier, , Germany

Site Status RECRUITING

European hospital

Roma, , Italy

Site Status RECRUITING

Mauriziano Hospital

Turin, , Italy

Site Status RECRUITING

Germans Trias i Pujol

Badalona, , Spain

Site Status RECRUITING

University hospital of the Canary Islands

Santa Cruz de Tenerife, , Spain

Site Status RECRUITING

Ribera hospital

Valencia, , Spain

Site Status RECRUITING

Cardiocentro Ticino

Lugano, , Switzerland

Site Status RECRUITING

Triemli University Hospital

Zurich, , Switzerland

Site Status RECRUITING

Countries

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Austria Germany Italy Spain Switzerland

Central Contacts

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Stefanos Demertzis, Professor

Role: CONTACT

+41918053147

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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