Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2024
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2023
CompletedFirst Posted
Study publicly available on registry
September 28, 2023
CompletedStudy Start
First participant enrolled
January 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
March 26, 2024
March 1, 2024
3 years
September 14, 2023
March 25, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Freedom from target vessel instability
primary patency and freedom from stenosis fo the semibranch
30 days after intervention
Mortality
overall mortality rate during 30 days after intervention
30 days after intervention
technical success
Feasibility in terms of cannulation and stentgrafting of the semibranches
During intervention
Secondary Outcomes (4)
Morbidity
During follow up period (up to 3 years)
freedom Endoleak Type I and III
During follow up period (up to 3 years)
Long term mortality
During follow up period (up to 3 years)
Branch patency
During follow up period (up to 3 years)
Interventions
bEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design
Eligibility Criteria
Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft.
You may qualify if:
- 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
You may not qualify if:
- Women of childbearing age
- Patients under 18 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Muenster University Hospital
Münster, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Alexander Oberhuber, MD,PhD
Department of Vascular and Endovascular Surgery University Hospital Münster
- PRINCIPAL INVESTIGATOR
Alexander Oberhuber, MD,PhD
Department of Vascular and Endovascular Surgery University Hospital Münster
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Univ.-Prof. Dr. med. Alexander Oberhuber
Study Record Dates
First Submitted
September 14, 2023
First Posted
September 28, 2023
Study Start
January 12, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
March 31, 2027
Last Updated
March 26, 2024
Record last verified: 2024-03