NCT04761068

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
5 countries

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2017

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2021

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2026

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

8.3 years

First QC Date

February 16, 2021

Last Update Submit

February 16, 2021

Conditions

Coronary Artery Disease

Keywords

Coronary artery bypass surgeryCABGExternal support

Outcome Measures

Primary Outcomes (1)

  • Ischemic driven target vessel revascularization

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

    5 years post Index CABG

Secondary Outcomes (4)

  • MACCE

    1, 2, and 5 years post index CABG

  • Myocardial Infarction (MI)

    1, 2, and 5 years post index CABG

  • Recurrent revascularization

    1, 2, and 5 years post index CABG

  • Survival

    1, 2, and 5 years post index CABG

Interventions

VESTDEVICE

Venous External Support for vein grafts in CABG

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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

Ribera hospital

Valencia, Spain

RECRUITING

Cardiocentro Ticino

Lugano, Switzerland

RECRUITING

Triemli University Hospital

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Stefanos Demertzis

    Cardiocentro Ticino

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanos Demertzis, Professor

CONTACT

+41918053147Stefanos.Demertzis@cardiocentro.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of cardiac surgery

Study Record Dates

First Submitted

February 16, 2021

First Posted

February 18, 2021

Study Start

December 15, 2017

Primary Completion

March 30, 2026

Study Completion

March 30, 2026

Last Updated

February 18, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(3)CH(2)AU(3)IT(2)ES(3)