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NCT Number: NCT06059053

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

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.

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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

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.

Who can participate

Healthy volunteers accepted: No

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

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

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 fo the semibranch

  2. Mortality

    Time frame: 30 days after intervention

    overall mortality rate during 30 days after intervention

  3. technical success

    Time frame: During intervention

    Feasibility in terms of cannulation and stentgrafting of 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 Endoleak Type I and III

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

    absence 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

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Oberhuber, MD,PhD

CONTACT

[email protected]

+492518345781

vascular trial unit

CONTACT

[email protected]

+492518351717

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 28, 2023
Registry last updated
Mar 26, 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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