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NCT06374355 Clinical Trial

Semibranch Registry - Retrospective

Aortic Aneurysm Clinical Trial

Official title:
Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Retrospective, Multicentre Registry

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06374355
Other study ID # Semibranch_Retro
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 2024
Est. completion date October 2030

Study information
Verified date April 2024
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair.

Description:

The main question it aims to answer are: - Patency of the semibranch - Feasibility of the technique regarding cannulation and stentgrafting

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date October 2030
Est. primary completion date April 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - Patient has been treated with the semibranch stentgraft - Patient is over 18 years old

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Semibranch CMD branched aortic stentgraft
bEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design

Locations
Country Name City State
Germany Muenster University Hospital Münster

Sponsors (1)
Lead Sponsor Collaborator
University Hospital Muenster

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Freedom from target vessel instability Primary patency and freedom from stenosis of the semibranch 30 days after intervention
Primary Mortality Overall mortality rate during 30 days after intervention 30 days after intervention
Primary Technical success cannulation and stentgrafting ot the semibranches 12 hours after intervention
Secondary Morbidity Access site, bowel ischemia, kidney failure, paraplegia During follow up period (up to 3 years)
Secondary Freedom of Endoleak type I and III Abscence of endoleaks arising from the semibranch During follow up period (up to 3 years)
Secondary Long term mortality Overall mortality up to 3 years During follow up period (up to 3 years)
Secondary Branch patency Primary patency of all branches During follow up period (up to 3 years)
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