Semibranch Registry - Retrospective

July 2, 2024 updated by: Univ.-Prof. Dr. med. Alexander Oberhuber, University Hospital Muenster

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

The goal of this registry is to evaluate the semibranch in branched endovascular arotic repair, which is a new tool in endovascular branched aortic repair.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The main question it aims to answer are:

  • Patency of the semibranch
  • Feasibility of the technique regarding cannulation and stentgrafting

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pararenal or thoracoabdominal aortic pathology, who are treated with a endovascular semibranch stentgraft

Description

  • Patient has been treated with the semibranch stentgraft
  • Patient is over 18 years old

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from target vessel instability
Time Frame: 30 days after intervention
Primary patency and freedom from stenosis of the semibranch
30 days after intervention
Mortality
Time Frame: 30 days after intervention
Overall mortality rate during 30 days after intervention
30 days after intervention
Technical success
Time Frame: 12 hours after intervention
cannulation and stentgrafting ot the semibranches
12 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morbidity
Time Frame: During follow up period (up to 3 years)
Access site, bowel ischemia, kidney failure, paraplegia
During follow up period (up to 3 years)
Freedom of Endoleak type I and III
Time Frame: During follow up period (up to 3 years)
Abscence of endoleaks arising from the semibranch
During follow up period (up to 3 years)
Long term mortality
Time Frame: During follow up period (up to 3 years)
Overall mortality up to 3 years
During follow up period (up to 3 years)
Branch patency
Time Frame: During follow up period (up to 3 years)
Primary patency of all branches
During follow up period (up to 3 years)

Collaborators and Investigators

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

Sponsor

University Hospital Muenster

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)

July 2, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

October 1, 2030

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 3, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Semibranch_Retro

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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