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

March 25, 2024 updated by: Univ.-Prof. Dr. med. Alexander Oberhuber, University Hospital Muenster
The goal of this registry is to evaluate the semibranch in branched endovascular aortic 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

The participants will treated with the custom made semibranch device and enrolled in the registry if they consent. No change in treatment will be made when enrolled.

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 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

  • 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

Inclusion Criteria:

  • 18 years or older
  • Presence of pararenal or thoracoabdominal aortic pathology
  • Treatment planned a semibranch device branch from Artivion
  • 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

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 fo 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: During intervention
Feasibility in terms of cannulation and stentgrafting of the semibranches
During 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 Endoleak Type I and III
Time Frame: During follow up period (up to 3 years)
absence 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

Investigators

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

January 12, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 22, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Semibranch_Reg

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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