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

Recruiting

• Conditions: Triple Branch; Aortic Arch Aneurysm; Dissection of Aortic Arch; Aortic Arch

• Registration Number: NCT05530304
• Lead Sponsor: University Hospital Muenster

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2023-02-09
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-13
• Primary Completion: 2026-12-31
• Study Completion: 2027-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
feasibility in terms of cannulation and stentgrafting of the three branches	During intervention
Stroke	30 days after intervention
Mortality	30 days after intervention

Secondary Outcome Measures

Name	Time	Method
Patency rate of branches	during the follow up period of 3 year	primary and secondary
Morbidity	during the follow up period of 3 year	Access issue, paraplegia, kidney failure
Endoleaks Type I and III	during intervention and the follow up period of 3 year
Longterm mortality	during the follow up period of 3 year
Stroke	during the follow up period of 3 year

Trial Locations

Locations (1)

Muenster University Hospital; 🇩🇪 Münster, Germany