Aortic Aneurysm, Endovascular Aortic Repair, Stent-Graft Endoleak
Conditions
Brief summary
The goal of this registry is to evaluate the semibranch in branched endovascular aortic repair, which is a new tool in endovascular branched aortic repair.
Detailed description
The main question it aims to answer are: * Patency of the semibranch * Feasibility of the technique regarding cannulation and stentgrafting The participants will treated with the custom made semibranch device and enrolled in the registry if they consent. No change in treatment will be made when enrolled.
Interventions
bEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design
Sponsors
University Hospital Muenster
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older * Presence of pararenal or thoracoabdominal aortic pathology * Treatment planned a semibranch device branch from Artivion * Availability of the patients during the follow up period * Informing patients about the study and providing written informed consent
Exclusion criteria
* Women of childbearing age * Patients under 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from target vessel instability | 30 days after intervention | primary patency and freedom from stenosis fo the semibranch |
| Mortality | 30 days after intervention | overall mortality rate during 30 days after intervention |
| technical success | During intervention | Feasibility in terms of cannulation and stentgrafting of the semibranches |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Morbidity | During follow up period (up to 3 years) | Access site, bowel ischemia, kidney failure, paraplegia |
| Branch patency | During follow up period (up to 3 years) | primary patency of all branches |
| freedom Endoleak Type I and III | During follow up period (up to 3 years) | absence of endoleaks arising from the semibranch |
| Long term mortality | During follow up period (up to 3 years) | overall mortality up to 3 years |
Countries
Germany
Contacts
Primary ContactAlexander Oberhuber, MD,PhD
Backup Contactvascular trial unit
Outcome results
None listed