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

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT04761068
• Lead Sponsor: Cardiocentro Ticino

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-15
• Status Verified: 2021-02
• Study First Submitted: 2021-02-16
• Study First Submitted QC: 2021-02-16
• Last Update Submitted: 2021-02-16
• Study First Posted: 2021-02-18
• Last Update Posted: 2021-02-18
• Primary Completion: 2026-03-30
• Study Completion: 2026-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ischemic driven target vessel revascularization	5 years post Index CABG	CABG or PCI of VEST supported vein graft or associated target coronary artery

Secondary Outcome Measures

Name	Time	Method
Recurrent revascularization	1, 2, and 5 years post index CABG	Recurrent revascularization
Myocardial Infarction (MI)	1, 2, and 5 years post index CABG	Myocardial Infarction (MI)
Survival	1, 2, and 5 years post index CABG	Survival, both overall and freedom from cardiac death
MACCE	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).

Trial Locations

Locations (13)

Herzzentrum Dresden; 🇩🇪 Dresden, Germany

Klinikum Nürnberg; 🇩🇪 Nürnberg, Germany

Krankenhaus der Barmherzigen Brüder; 🇩🇪 Trier, Germany

Germans Trias i Pujol; 🇪🇸 Badalona, Spain

University hospital of the Canary Islands; 🇪🇸 Santa Cruz De Tenerife, Spain

Ribera hospital; 🇪🇸 Valencia, Spain

Medical University of Innsbruck; 🇦🇹 Innsbruck, Austria

AKH (Vienna General Hospital); 🇦🇹 Vienna, Austria

Cardiocentro Ticino; 🇨🇭 Lugano, Switzerland

Floridsdorf Clinic; 🇦🇹 Vienna, Austria

Triemli University Hospital; 🇨🇭 Zürich, Switzerland

Mauriziano Hospital; 🇮🇹 Turin, Italy

European hospital; 🇮🇹 Roma, Italy