Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

Last updated: May 5, 2025
Sponsor: W.L.Gore & Associates
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chest Pain

Aneurysm

Occlusions

Treatment

GORE® TAG® Thoracic Branch Endoprosthesis

Clinical Study ID

NCT06507865
TGR 23-02TB
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion Criteria:

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.

Patient with exclusion criteria required by local law. Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: GORE® TAG® Thoracic Branch Endoprosthesis
Phase:
Study Start date:
February 20, 2025
Estimated Completion Date:
April 30, 2031

Study Description

The purpose of the GORE® TAG® Thoracic Branch Endoprosthesis Registry is to collect real-world data for this device. Due to the nature of the registry, patient selection, diagnostic imaging, and treatment interventions will be determined by physicians based on standard clinical practice. Therefore, the Sponsor will not be outlining requirements that would influence healthcare decisions.

Participants will be asked to return for regular scheduled visits as requested by their surgeon. Patients will report any issues they may have regarding the device or surgery to their surgeon/doctor.

Connect with a study center

  • Medizinische Universität Wien

    Wien, A-1090
    Austria

    Active - Recruiting

  • Rigshospitalet University Hospital

    Copenhagen, 2100
    Denmark

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Suspended

  • University of Heidelberg

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Muenster, 48149
    Germany

    Site Not Available

  • Evangelismos General Hospital

    Athens, 106 76
    Greece

    Active - Recruiting

  • Laiko General hospital of Athens

    Athens, 11527
    Greece

    Site Not Available

  • Policlinico di Sant'Orsola

    Bologna, 40138
    Italy

    Site Not Available

  • ASST Spedali Civili di Brescia

    Brescia, 25123
    Italy

    Active - Recruiting

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132
    Italy

    Active - Recruiting

  • AOU Padova

    Padova, 35128
    Italy

    Site Not Available

  • Azienda Ospedaliera "G. Brotzu"

    Selargius, 09047
    Italy

    Site Not Available

  • Amsterdam UMC

    Amsterdam, 1105 AZ
    Netherlands

    Active - Recruiting

  • Radboud UMC

    Nijmegen, 6525 GA
    Netherlands

    Active - Recruiting

  • Complejo Hospitalario Universitario de Vigo

    Vigo, 36312
    Spain

    Site Not Available

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009
    Spain

    Site Not Available

  • Skane University Hospital

    Malmö, 205 02
    Sweden

    Site Not Available

  • St Mary's Hospital

    London, W2 1NY
    United Kingdom

    Site Not Available

  • St Thomas' Hospital

    London, SE1 7EH
    United Kingdom

    Site Not Available

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