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

NCT05530304 | Recruiting

• 1 other identifier: University_Hospital_Muenster
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Aortic Arch; Aortic Arch Aneurysm; Dissection of Aortic Arch; Triple Branch

Keywords

Aortic arch pathologies; Aortic arch aneruysm; Aortic arch dissection; triple branch; stentgraft; Double branch; Inner branch

Outcome Measures

Primary Outcomes (3)

• Mortality

  30 days after intervention

• feasibility in terms of cannulation and stentgrafting of the three branches

  During intervention

• Stroke

  30 days after intervention

Secondary Outcomes (5)

• Morbidity

  during the follow up period of 3 year

• 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

• Patency rate of branches

  during the follow up period of 3 year

• Stroke

  during the follow up period of 3 year

Interventions

Triple inner branched arch stentgraft DEVICE

New findings regarding treatment planning and management of patients with aortic arch pathologies.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from patients presenting to participating hospitals with aortic pathology and meeting inclusion and exclusion criteria.

You may qualify if:

• 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

You may not qualify if:

• Women of childbearing age
• Patients under 18 years

Sponsors & Collaborators

• University Hospital Muenster: lead

Study Sites (1)

Muenster University Hospital

Münster, Germany

RECRUITING

MeSH Terms

Conditions

Aneurysm, Aortic Arch; Dissection, Thoracic Aorta

Condition Hierarchy (Ancestors)

Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Aortic Dissection; Dissection, Blood Vessel; Acute Aortic Syndrome

Study Officials

• Alexander Oberhuber, MD, PhD

  Department of Vascular and Endovascular Surgery University Hospital Münster

  STUDY CHAIR

Central Study Contacts

Alexander Oberhuber, MD, PhD

CONTACT

+49 251 8345781; alexander.oberhuber@ukmuenster.de

vascular trial unit

CONTACT

+49 251 8351717; vital@ukmuenster.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ.-Prof. Dr. med.

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 7, 2022
• Study Start: February 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

DE (1)