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NCT Number: NCT06374355

Semibranch Registry - Retrospective

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.

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Key information

Conditions

Aortic Aneurysm Aneurysm Aortic Diseases Cardiovascular Diseases Endovascular Aortic Repair Stent-Graft Endoleak Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Muenster University Hospital

Münster, Germany

Location status: Recruiting

Location contact

Alexander Oberhuber, MD Phd

CONTACT

[email protected]

+49 251 8345781

Alexander Oberhuber, MD Phd

PRINCIPAL_INVESTIGATOR

About this study

The main question it aims to answer are:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semibranch CMD branched aortic stentgraft

Device

bEVAR with a custom made abdominal aortic multibranch, which incorporates the semibranch design

Primary outcomes

  1. Freedom from target vessel instability

    Time frame: 30 days after intervention

    Primary patency and freedom from stenosis of the semibranch

  2. Mortality

    Time frame: 30 days after intervention

    Overall mortality rate during 30 days after intervention

  3. Technical success

    Time frame: 12 hours after intervention

    cannulation and stentgrafting ot the semibranches

Secondary outcomes

  1. Morbidity

    Time frame: During follow up period (up to 3 years)

    Access site, bowel ischemia, kidney failure, paraplegia

  2. Freedom of Endoleak type I and III

    Time frame: During follow up period (up to 3 years)

    Abscence of endoleaks arising from the semibranch

  3. Long term mortality

    Time frame: During follow up period (up to 3 years)

    Overall mortality up to 3 years

  4. Branch patency

    Time frame: During follow up period (up to 3 years)

    Primary patency of all branches

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Apr 18, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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