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

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: Coronary Artery Disease
• Intervention / Treatment: Device: VEST

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Stefanos Demertzis, Professor; Phone Number: +41918053147; Email: Stefanos.Demertzis@cardiocentro.org

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

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cardiocentro Ticino
• Investigators: Principal Investigator: Stefanos Demertzis, Cardiocentro Ticino

Study record dates

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: CABG; Coronary artery bypass surgery; External support
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• 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