Clinical trial NCT04761068: Clinical Outcomes of Patients Undergoing CABG Surgery With VEST Supported Venous Grafts
Official title: Clinical Outcomes of Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery With VEST Supported Venous Grafts
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Coronary Artery Disease
Keywords: Coronary artery bypass surgery
CABG
External support
Lead sponsor: Cardiocentro Ticino
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient scheduled for planned CABG procedure with at least one SVG bypass with pre-planned VEST treatment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Ischemic driven target vessel revascularization
timeFrame: 5 years post Index CABG
Secondary outcomes:
measure: MACCE
timeFrame: 1, 2, and 5 years post index CABG
measure: Myocardial Infarction (MI)
timeFrame: 1, 2, and 5 years post index CABG
measure: Recurrent revascularization
timeFrame: 1, 2, and 5 years post index CABG
measure: Survival
timeFrame: 1, 2, and 5 years post index CABG
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Vienna
country: Austria
facility: AKH (Vienna General Hospital)
city: Vienna
country: Austria
facility: Floridsdorf Clinic
city: Dresden
country: Germany
facility: Herzzentrum Dresden
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg
city: Trier
country: Germany
facility: Krankenhaus der Barmherzigen Brüder
city: Roma
country: Italy
facility: European hospital
city: Turin
country: Italy
facility: Mauriziano Hospital
city: Badalona
country: Spain
facility: Germans Trias i Pujol
city: Santa Cruz De Tenerife
country: Spain
facility: University hospital of the Canary Islands
city: Valencia
country: Spain
facility: Ribera hospital
city: Lugano
country: Switzerland
facility: Cardiocentro Ticino
city: Zürich
country: Switzerland
facility: Triemli University Hospital
Study officials:
affiliation: Cardiocentro Ticino
name: Stefanos Demertzis
role: PRINCIPAL_INVESTIGATOR
References: