Actively Recruiting

Age: 18Years +
All Genders
ID06374355

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

Led by University Hospital Muenster · Updated on 2024-07-03

100

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate a new tool called the semibranch in branched endovascular aortic repair, which is used to treat aortic aneurysms and related conditions. The study focuses on understanding how well the semibranch remains open (patency) and whether the technique for placing it is feasible, particularly regarding the ability to access and place the stentgraft. Participants in this observational registry have already been treated with a custom-made abdominal aortic multibranch stentgraft that includes the semibranch design. The study collects data retrospectively from multiple centers to assess outcomes related to this device and procedure. Throughout the study, researchers will review key measures such as freedom from vessel instability and mortality within 30 days after the procedure, as well as technical success shortly after intervention. They will also track longer-term outcomes including morbidity, endoleaks, mortality, and the ongoing openness of the branch over a follow-up period of up to three years.

CONDITIONS

Brief Title

Semibranch Registry - Retrospective

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient has been treated with the semibranch stentgraft
  • Patient is over 18 years old
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Screening and enrollment visit

Implementation

Duration - Single procedure with immediate post-procedure period

Participants undergo placement of the semibranch custom made abdominal aortic multibranch stentgraft device.

1 procedure visit (in-person)

Post-operative Follow-up

Duration - Up to 3 years

Participants are followed up to monitor outcomes such as vessel patency, mortality, morbidity, and endoleak occurrence.

Approximately 6 to 12 follow-up visits over 3 years

Trial Site Locations

Total: 1 location

1

Muenster University Hospital

Münster, Germany

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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