An observational study in Aortic Aneurysm, Endovascular Aortic Repair and Stent-Graft Endoleak, sponsored by University Hospital Muenster. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-26.
Sponsored by University Hospital Muenster · Observational
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.
The main question it aims to answer are:
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.
222 studies on the registry are indexed under Aortic Aneurysm; 63 are open to participants now.
This study's planned enrollment of 100 is below the median of 150 across 117 observational studies indexed under Aortic Aneurysm.
Browse Aortic Aneurysm studies →University Hospital Muenster is the lead sponsor of 192 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
bEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design
Freedom from target vessel instability
primary patency and freedom from stenosis fo the semibranch
Time frame: 30 days after intervention
Mortality
overall mortality rate during 30 days after intervention
Time frame: 30 days after intervention
technical success
Feasibility in terms of cannulation and stentgrafting of the semibranches
Time frame: During intervention
Morbidity
Access site, bowel ischemia, kidney failure, paraplegia
Time frame: During follow up period (up to 3 years)
freedom Endoleak Type I and III
absence of endoleaks arising from the semibranch
Time frame: During follow up period (up to 3 years)
Long term mortality
overall mortality up to 3 years
Time frame: During follow up period (up to 3 years)
Branch patency
primary patency of all branches
Time frame: During follow up period (up to 3 years)
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jan 2024 (actual). Primary completion is estimated for Dec 2026, 35 months after the start.
Of 44 observational studies under Aortic Aneurysm, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 107. This study's planned 35 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
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