Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

Aortic Arch Aneurysm Clinical Trial

— triple_branch  

Official title:

Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530304
• Other study ID #: University_Hospital_Muenster
• Status: Recruiting
• Start date: February 9, 2023
• Est. completion date: March 31, 2027

Study information

• Verified date: September 2023
• Source: University Hospital Muenster
• Contact: Alexander Oberhuber, MD, PhD
• Phone: +49 251 8345781
• Email: alexander.oberhuber[@]ukmuenster.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 18 years or older

• Presence of Aortic arch pathology

• Treatment planned with triple inner branch from Terumo Aortic

• 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 Arch
• Aortic Arch Aneurysm

Intervention

Device:
• Triple inner branched arch stentgraft
New findings regarding treatment planning and management of patients with aortic arch pathologies.

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	Mortality		30 days after intervention
Primary	feasibility in terms of cannulation and stentgrafting of the three branches		During intervention
Primary	Stroke		30 days after intervention
Secondary	Morbidity	Access issue, paraplegia, kidney failure	during the follow up period of 3 year
Secondary	Endoleaks Type I and III		during intervention and the follow up period of 3 year
Secondary	Longterm mortality		during the follow up period of 3 year
Secondary	Patency rate of branches	primary and secondary	during the follow up period of 3 year
Secondary	Stroke		during the follow up period of 3 year