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NCT Number: NCT05530304

Outcome of a Triple Inner Branched Aortic Arch Stentgraft. A Prospective, Multicenter Registry.

Outcome of a triple inner branched aortic arch stentgraft. A prospective, mulitcenter registry.

Recruiting

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Key information

Conditions

Aortic Arch Acute Aortic Syndrome Aneurysm Aneurysm, Aortic Arch Aortic Aneurysm Aortic Aneurysm, Thoracic Aortic Arch Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection of Aortic Arch Dissection, Blood Vessel Dissection, Thoracic Aorta Triple Branch Vascular Diseases

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

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 Aortic arch pathology
  • Treatment planned with triple inner branch from Terumo Aortic
  • 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

Triple inner branched arch stentgraft

Device

New findings regarding treatment planning and management of patients with aortic arch pathologies.

Primary outcomes

  1. Mortality

    Time frame: 30 days after intervention

  2. feasibility in terms of cannulation and stentgrafting of the three branches

    Time frame: During intervention

  3. Stroke

    Time frame: 30 days after intervention

Secondary outcomes

  1. Morbidity

    Time frame: during the follow up period of 3 year

    Access issue, paraplegia, kidney failure

  2. Endoleaks Type I and III

    Time frame: during intervention and the follow up period of 3 year

  3. Longterm mortality

    Time frame: during the follow up period of 3 year

  4. Patency rate of branches

    Time frame: during the follow up period of 3 year

    primary and secondary

  5. Stroke

    Time frame: during the follow up period of 3 year

Study contacts

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

Alexander Oberhuber, MD, PhD

CONTACT

[email protected]

+49 251 8345781

vascular trial unit

CONTACT

[email protected]

+49 251 8351717

Sponsors and collaborators

Lead sponsor

University Hospital Muenster

Other

Registry information

Acronym: triple_branch

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 7, 2022
Registry last updated
Sep 13, 2023

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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