RecruitingNCT06507865

Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention


Sponsor

W.L.Gore & Associates

Enrollment

200 participants

Start Date

Feb 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.


Eligibility

Min Age: 18 Years

Inclusion Criteria1

  • Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements Patient has been or is intended to be treated with an eligible registry device Patient is age ≥ 18 years at time of informed consent signature.

Exclusion Criteria1

  • Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.

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Interventions

DEVICEGORE® TAG® Thoracic Branch Endoprosthesis

Patients presenting with thoracic vascular disease that may benefit from the placement of TBE device. The target registry population is patients who are treated with TBE at participating sites. TBE treatment is qualified as receiving the TBE aortic component, at a minimum.


Locations(20)

Medizinische Universität Wien

Vienna, Austria

Rigshospitalet University Hospital

Copenhagen, Denmark

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, Germany

University of Heidelberg

Heidelberg, Germany

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Universitätsklinikum Münster

Münster, Germany

Evangelismos General Hospital

Athens, Greece

Laiko General hospital of Athens

Athens, Greece

Policlinico di Sant'Orsola

Bologna, Italy

ASST Spedali Civili di Brescia

Brescia, Italy

IRCCS Ospedale Policlinico San Martino

Genova, Italy

AOU Padova

Padova, Italy

Azienda Ospedaliera "G. Brotzu"

Selargius, Italy

Amsterdam UMC

Amsterdam, Netherlands

Radboud UMC

Nijmegen, Netherlands

Complejo Hospitalario Universitario de Vigo

Vigo, Spain

Hospital Universitario Miguel Servet

Zaragoza, Spain

Skane University Hospital

Malmo, Sweden

St Thomas' Hospital

London, United Kingdom

St Mary's Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06507865


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