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NCT Number: NCT06276413

REgistRy BRAnch goRE EndopRosthEsis

Multicenter registry on patients treated by the new Gore thoracic branched endoprosthesis

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Key information

Conditions

Aortic Aneurysm, Thoracic Acute Aortic Syndrome Aneurysm Aortic Aneurysm Aortic Diseases Aortic Dissection Cardiovascular Diseases Dissection, Blood Vessel Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vascular and Endovascular Clinic - Padova University

Padova, 35020, Italy

Location contact

Michele Piazza, Pr

CONTACT

[email protected]

3498644688

About this study

This is a multicenter, non-sponsored, physician-initiated multicenter registry on patients treated with the Gore thoracic branched endoprosthesis.

Inclusion of centers is on a voluntary basis; each participating center includes consecutive patients treated with this device.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients receving the Gore TAG thoracic branched endograft for thoracic aorta pathologies

Exclusion criteria

  • less than 18 years
  • allergy to endograft components
  • patients receiving other types of arch endografts

Treatment and study plan

GORE TAG Thoracic Branch Endoprosthesis

Device

deployment of the GORE TAG Thoracic Branch Endoprosthesis fro thoraci aorta pathologies

Primary outcomes

  1. early mortality

    Time frame: 30 days

    mortality related to the intervention within 30 days

  2. device stability

    Time frame: 5 years

    freedom from related mortality, reintervention, type 1a endoleak during follow-up

  3. technical success

    Time frame: 30 days

    succesful deployment of all endograft components at the intended site with complete aneurysm exclusion, without surgical conversion, type Ia/III endoleak, kink, stenosis, graft occlusion

Secondary outcomes

  1. early major adverse events

    Time frame: 30 days

    stroke, spinal cord ischemia, vascular complications, cardiac complications, respiratory insufficiency, early reintervention, acute kidney injury

Study contacts

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

Michele Antonello, PhD

CONTACT

[email protected]

0498212636

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

Registry on Gore Branch Endoprosthesis

Acronym: REBRA

Important dates

Study start
2024
Primary completion
2025
Study completion
2030
First posted
Feb 26, 2024
Registry last updated
Feb 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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