NCT05439395

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

Multi Center, International, Single-arm, Retrospective, Observational Post Market Clinical Follow-Up (PMCF) Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure in Patients Undergoing Cardiac Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 229 (actual)
• Sponsor: Aesculap AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Coronary Artery Disease
• Cardiac Valve Insufficiency
• Aortic Valve Stenosis

Interventions

Type	Name	Description
DEVICE	Sternum Closure after Cardiac Surgery	Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.

Timeline

• Start date: 2022-05-18
• Primary completion: 2022-10-01
• Completion: 2023-04-07
• First posted: 2022-06-30
• Last updated: 2023-04-13

Locations

2 sites across 2 countries: Germany, Spain