Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure (STERCCAS)

Aesculap

Status

Completed

Conditions

Coronary Artery Disease

Cardiac Valve Insufficiency

Aortic Valve Stenosis

Treatments

Device: Sternum Closure after Cardiac Surgery

Study type

Observational

Funder types

Industry

Identifiers

NCT05439395

AAG-O-H-2028

Details and patient eligibility

About

The study is designed as a retrospective, international, multi-center cohort study to evaluate Steelex® Sternum Set for sternum closure. The data from 2 clinics located in Germany and Spain participating in the "OPTICABG" as well as in the "PREMIVALVE" study will be used for assessment. Only patients receiving a complete or a partial sternotomy closed with Steelex® Sternum Set will be included in the analysis. "OPTICABG" patients were followed up 3 months after surgery and "PREMIVALVE" patients until 6 months after surgery. Adverse Events (AE) / Serious Adverse Events (SAE)(e.g. surgical site infection, sternum stability, stroke, myocardial infraction, death etc.) reported in both studies will be used for the STERCCAS analysis.

Enrollment

229 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

OPTICABG study patients undergoing an elective, primary coronary artery bypass graft surgery (CABG) receiving a sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
PREMIVALVE study patients undergoing a cardiac valve replacement or reconstruction receiving a complete or partial sternotomy, by whom the sternum was closed using Steelex® Sternum Set.
Eligible patients from the OPTICABG study and PREMIVALVE study who have provided their written informed consent
Age ≥18 years

Exclusion criteria