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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761068
• Other study ID #: VEST registry
• Status: Recruiting
• Start date: December 15, 2017
• Est. completion date: March 30, 2026

Study information

• Verified date: February 2021
• Source: Cardiocentro Ticino
• Contact: Stefanos Demertzis, Professor
• Phone: +41918053147
• Email: Stefanos.Demertzis[@]cardiocentro.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 30, 2026
• Est. primary completion date: March 30, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• VEST
Venous External Support for vein grafts in CABG

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Austria	AKH (Vienna General Hospital)	Vienna
Austria	Floridsdorf Clinic	Vienna
Germany	Herzzentrum Dresden	Dresden
Germany	Klinikum Nürnberg	Nürnberg
Germany	Krankenhaus der Barmherzigen Brüder	Trier
Italy	European hospital	Roma
Italy	Mauriziano Hospital	Turin
Spain	Germans Trias i Pujol	Badalona
Spain	University hospital of the Canary Islands	Santa Cruz De Tenerife
Spain	Ribera hospital	Valencia
Switzerland	Cardiocentro Ticino	Lugano
Switzerland	Triemli University Hospital	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Cardiocentro Ticino

Countries where clinical trial is conducted

Austria,  Germany,  Italy,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemic driven target vessel revascularization	CABG or PCI of VEST supported vein graft or associated target coronary artery	5 years post Index CABG
Secondary	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
Secondary	Myocardial Infarction (MI)	Myocardial Infarction (MI)	1, 2, and 5 years post index CABG
Secondary	Recurrent revascularization	Recurrent revascularization	1, 2, and 5 years post index CABG
Secondary	Survival	Survival, both overall and freedom from cardiac death	1, 2, and 5 years post index CABG