Retrospective, Single-Centre Data Collection Study of the Effectiveness and Safety of a Specially Designed Ductus Arteriosus Self-Expanding Stent (Sinus-SuperFlex-DS, SSF) in the Giessen Hybrid” Approach
- Conditions
- Q23.4Hypoplastic left heart syndrome
- Registration Number
- DRKS00025766
- Lead Sponsor
- optimed Medizinische Instrumente GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
1. Patients treated with the Giessen Hybrid” approach
2. Patient underwent the following procedure: Giessen Hybrid” Approach Stage I (including: surgical bilateral pulmonary artery banding (bPAB) and implantation of the SSF-DS in the PDA)
Exclusion Criteria
1. Lost to follow-up during Interstage I
2. Unavailable outcome data at planned assessment time points
3. Incomplete data for gender, disease presentation, and reason(s) for change of medication / intervention
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival after completed Stage I (30-day mortality)
- Secondary Outcome Measures
Name Time Method - Overall survival during Interstage I<br>- Complication-free survival during Interstage I<br>- Overall survival during Comprehensive Stage II surgery (30-day mortality)<br>- Overall survival after Comprehensive Stage II surgery (till Fontan surgery)<br>- Complication-free survival after Comprehensive Stage II surgery (till Fontan surgery)<br>- Overall survival during Fontan surgery Stage III<br>- Overall survival after Fontan surgery Stage III<br>- Complication-free survival after Fontan surgery Stage III<br>- Angiographic measurements of the Ductus and the stent before, during and after Giessen Hybrid Approach surgery (Stage I) (at least 10 data sets, Vessel diameter of ductus arteriosus, Bending radius of stent, Bending length of stent)