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

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
View:

• 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

Locations
Other Locations
Austria
Medical University of Innsbruck
RECRUITING
Innsbruck
AKH (Vienna General Hospital)
RECRUITING
Vienna
Floridsdorf Clinic
RECRUITING
Vienna
Germany
Herzzentrum Dresden
TERMINATED
Dresden
Klinikum Nürnberg
RECRUITING
Nuremberg
Krankenhaus der Barmherzigen Brüder
RECRUITING
Trier
Italy
European hospital
RECRUITING
Roma
Mauriziano Hospital
RECRUITING
Turin
Spain
Germans Trias i Pujol
RECRUITING
Badalona
University hospital of the Canary Islands
RECRUITING
Santa Cruz De Tenerife
Ribera hospital
RECRUITING
Valencia
Switzerland
Cardiocentro Ticino
RECRUITING
Lugano
Triemli University Hospital
RECRUITING
Zurich
Contact Information
Primary
Stefanos Demertzis, Professor
Stefanos.Demertzis@cardiocentro.org
+41918053147
Time Frame
Start Date: 2017-12-15
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 1000
Sponsors
Leads: Cardiocentro Ticino

This content was sourced from clinicaltrials.gov