Status:
COMPLETED
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
Lead Sponsor:
Aesculap AG
Collaborating Sponsors:
B.Braun Surgical SA
Conditions:
Coronary Artery Disease
Cardiac Valve Insufficiency
Eligibility:
All Genders
18+ years
Brief 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 participat...
Eligibility Criteria
Inclusion
- 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
- OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.
Key Trial Info
Start Date :
May 18 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 7 2023
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT05439395
Start Date
May 18 2022
End Date
April 7 2023
Last Update
April 13 2023
Active Locations (2)
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1
Robert Bosch KH Stuttgart
Stuttgart, Germany, 70376
2
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain, 08026