Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.

Aortic Aneurysm Clinical Trial

Official title:

Outcome of the Semibranch in Pararenal and Thoracoabdominal Aortic Pathologies. A Prospective, Multicentre Registry.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059053
• Other study ID #: Semibranch_Reg
• Status: Recruiting
• Start date: January 12, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: March 2024
• Source: University Hospital Muenster
• Contact: Alexander Oberhuber, MD,PhD
• Phone: +492518345781
• Email: alexander.oberhuber[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Endoleak
• Endovascular Aortic Repair
• Stent-Graft Endoleak

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 fo the semibranch	30 days after intervention
Primary	Mortality	overall mortality rate during 30 days after intervention	30 days after intervention
Primary	technical success	Feasibility in terms of cannulation and stentgrafting of the semibranches	During intervention
Secondary	Morbidity	Access site, bowel ischemia, kidney failure, paraplegia	During follow up period (up to 3 years)
Secondary	freedom Endoleak Type I and III	absence 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)