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

February 16, 2021 updated by: Stefanos Demertzis, Cardiocentro Ticino

Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery With VEST Supported Venous Grafts

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Innsbruck, Austria
        • Recruiting
        • Medical University of Innsbruck
        • Principal Investigator:
          • Nikolaus Bonaros, MD
      • Vienna, Austria
        • Recruiting
        • AKH (Vienna General Hospital)
        • Principal Investigator:
          • Sigrid Sandner, MD
      • Vienna, Austria
        • Recruiting
        • Floridsdorf Clinic
        • Principal Investigator:
          • Martin Grabenwoger, MD
  • Germany
      • Dresden, Germany
        • Terminated
        • Herzzentrum Dresden
      • Nürnberg, Germany
        • Recruiting
        • Klinikum Nürnberg
        • Principal Investigator:
          • Theodor Fischlein, MD
      • Trier, Germany
        • Recruiting
        • Krankenhaus der Barmherzigen Brüder
        • Principal Investigator:
          • Ivar Friedrich, MD
  • Italy
      • Roma, Italy
        • Recruiting
        • European Hospital
        • Principal Investigator:
          • Luca Waltert, MD
      • Turin, Italy
        • Recruiting
        • Mauriziano Hospital
        • Principal Investigator:
          • Paolo Centofanti, MD
  • Spain
      • Badalona, Spain
        • Recruiting
        • Germans Trias i Pujol
        • Principal Investigator:
          • Christian Muñoz, MD
      • Santa Cruz De Tenerife, Spain
        • Recruiting
        • University hospital of the Canary Islands
        • Principal Investigator:
          • Pilar Garrido, MD
      • Valencia, Spain
        • Recruiting
        • Ribera hospital
        • Principal Investigator:
          • Juan Antonio Margarit, MD
  • Switzerland
      • Lugano, Switzerland
        • Recruiting
        • Cardiocentro Ticino
        • Contact:
          • Stefanos Demertzis, Professor
        • Principal Investigator:
          • Stefanos Demertzis, Professor
      • Zürich, Switzerland
        • Recruiting
        • Triemli University Hospital
        • Principal Investigator:
          • Omer Dzemali, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ischemic driven target vessel revascularization
Time Frame: 5 years post Index CABG
CABG or PCI of VEST supported vein graft or associated target coronary artery
5 years post Index CABG

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MACCE
Time Frame: 1, 2, and 5 years post index CABG
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)
Time Frame: 1, 2, and 5 years post index CABG
Myocardial Infarction (MI)
1, 2, and 5 years post index CABG
Recurrent revascularization
Time Frame: 1, 2, and 5 years post index CABG
Recurrent revascularization
1, 2, and 5 years post index CABG
Survival
Time Frame: 1, 2, and 5 years post index CABG
Survival, both overall and freedom from cardiac death
1, 2, and 5 years post index CABG

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiocentro Ticino

Investigators

  • Principal Investigator: Stefanos Demertzis, Cardiocentro Ticino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 15, 2017

Primary Completion (Anticipated)

March 30, 2026

Study Completion (Anticipated)

March 30, 2026

Study Registration Dates

First Submitted

February 16, 2021

First Submitted That Met QC Criteria

February 16, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 16, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VEST registry

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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