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

September 11, 2023 updated by: Univ.-Prof. Dr. med. Alexander Oberhuber, University Hospital Muenster
Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Münster, Germany
        • Recruiting
        • Muenster University Hospital
        • Contact:
        • Principal Investigator:
          • Alexander Oberhuber, MD Phd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 30 days after intervention
30 days after intervention
feasibility in terms of cannulation and stentgrafting of the three branches
Time Frame: During intervention
During intervention
Stroke
Time Frame: 30 days after intervention
30 days after intervention

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Investigators

  • Study Chair: Alexander Oberhuber, MD, PhD, Department of Vascular and Endovascular Surgery University Hospital Münster

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 2, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 13, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • University_Hospital_Muenster

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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