Coronary Artery DiseaseSTERCCASNCT05439395
Study on the Clinical Performance of Steelex® Sternum Set for Sternal Closure
An observational study of Coronary Artery Disease and Cardiac Valve Insufficiency, run by Aesculap AG at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Cardiac Valve Insufficiency, Aortic Valve Stenosis
- What is being tested?
- Sternum Closure after Cardiac Surgery
- Type of treatment
- Medical device
- How many people
- 229 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 18 May 2022to 7 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving a partial or a complete sternotomy closed with Steelex Sternum Set participating either in the OPTICABG or PREMIVALVE study.
Who may be able to join
- 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
Who cannot join
- OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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
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.
- Being tested
- Sternum Closure after Cardiac Surgery
- Keywords
- Median Sternotomy, Partial Sternotomy, Coronary Artery Bypass Grafting (CABG), Cardiac Valve Replacement, Cardiac Valve Reconstruction
- Medical subject headings
- Coronary Artery Disease, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sternum Closure after Cardiac SurgeryDevice
Sternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| STEELEX | Steelex® Sternum Set for sternal closure Receives: Device: Sternum Closure after Cardiac Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection
Combination of:
- Incidence of sternum instability
- Incidence of sternum dehiscence
- Incidence of superficial and deep sternal wound infection according to classification of Centers for Disease Control and Prevention (CDC)
Measured: up to 6 months after surgery
Secondary outcomes (9)
Incidence of sternum instability
Number of patients presenting with instability of the sternum after sternal closure with Steelex® Sternum Set
Measured: up to 6 months after surgery
Incidence of sternum dehiscence
Number of patients presenting with dehiscence of the sternum after sternal closure with Steelex® Sternum Set
Measured: up to 6 months after surgery
Incidence of superficial and deep sternal wound infection
Number of patients presenting with superficial and deep sternal wound infection according to CDC classification after sternal closure with Steelex® Sternum Set
Measured: up to 6 months after surgery
Incidence of other cardiac and cerebral complications
Number of patients presenting with other cardiac and cerebral complications such as stroke, myocardial infarction, death, as well as mediastinitis after sternal closure with Steelex® Sternum Set
Measured: up to 6 months after surgery
Incidence of suture related complications
Number of patients presenting with suture related complications (e.g. wire breakage) after sternal closure with Steelex® Sternum Set
Measured: up to 6 months after surgery
Length of hospital stay
Number of days the patient has to stay in hospital
Measured: until discharge (approximately 10 days postoperative)
Length of intensive care unit stay
Number of days the patient has to stay in intensive care unit after intervention
Measured: until discharge (approximately 10 days postoperative)
Health Status measured with EQ-5D-5L Score
EQ-5D-5L is a Quality of Life Score introduced by the EuroQol Group. The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).
Descriptive system comprises five dimensions (5D): mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels (5L): no problems, slight problems, moderate problems, severe problems, extreme problems. Each answer results in a 1-digit number. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
Measured: up to 6 months after surgery
Intraoperative handling of the Steelex® Sternum Set
the handling is examined using a survey, which will be answered and filled out prospectively and anonymously once by all involved cardiac surgeons
Measured: at time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start18 May 2022
- Primary completion1 Oct 2022
- Study completion7 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Aesculap AGThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439395
- Sponsor's protocol ID
- AAG-O-H-2028
- Acronym
- STERCCAS
- Status last verified
- Apr 2023
- First submitted
- 22 Jun 2022
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05439395
- Acronym / sponsor ID
- STERCCAS / AAG-O-H-2028
- Keywords
- Median Sternotomy, Partial Sternotomy, Coronary Artery Bypass Grafting (CABG), Cardiac Valve Replacement, Cardiac Valve Reconstruction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- 18 May 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 7 Apr 2023 (actual)
- First posted
- 30 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STEELEX | – | Device: Sternum Closure after Cardiac SurgerySteelex® Sternum Set for sternal closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving a partial or a complete sternotomy closed with Steelex Sternum Set participating either in the OPTICABG or PREMIVALVE study.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- OPTICABG and PREMIVALVE patients receiving a sternotomy or partial sternotomy which was not closed with Steelex® Sternum Set.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sternum Closure after Cardiac SurgerySternal closure using Steelex® Sternum Set after CABG or cardiac valve replacement / reconstruction. | Device | STEELEX |
Primary outcome
Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection
Time frame: up to 6 months after surgery
Combination of: * Incidence of sternum instability * Incidence of sternum dehiscence * Incidence of superficial and deep sternal wound infection according to classification of Centers for Disease Control and Prevention (CDC)
9 secondary outcomes
Incidence of sternum instability
Time frame: up to 6 months after surgery
Incidence of sternum dehiscence
Time frame: up to 6 months after surgery
Incidence of superficial and deep sternal wound infection
Time frame: up to 6 months after surgery
Incidence of other cardiac and cerebral complications
Time frame: up to 6 months after surgery
Incidence of suture related complications
Time frame: up to 6 months after surgery
Length of hospital stay
Time frame: until discharge (approximately 10 days postoperative)
Length of intensive care unit stay
Time frame: until discharge (approximately 10 days postoperative)
Health Status measured with EQ-5D-5L Score
Time frame: up to 6 months after surgery
Intraoperative handling of the Steelex® Sternum Set
Time frame: at time of surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Cardiac Valve Insufficiency, run by Aesculap AG at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of a composite endpoint consisting of sternum instability, sternum dehiscence, superficial and deep sternal wound infection (time frame: up to 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.