Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis

NCT ID: NCT06507865

Last Updated: 2025-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-20

Study Completion Date

2031-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Aneurysm Dissection, Aortic TAA Thoracoabdominal Aortic Aneurysm Thoracic Aortic Aneurysm Transection Aorta

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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GORE® TAG® Thoracic Branch Endoprosthesis

Patients treated with the TBE Device

GORE® TAG® Thoracic Branch Endoprosthesis

Intervention Type DEVICE

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.

Interventions

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GORE® 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.

Intervention Type DEVICE

Other Intervention Names

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TBE device

Eligibility Criteria

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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 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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W.L.Gore & Associates

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medizinische Universität Wien

Vienna, , Austria

Site Status RECRUITING

Rigshospitalet University Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Universitätsklinikum Carl Gustav Carus Dresden

Dresden, , Germany

Site Status SUSPENDED

University of Heidelberg

Heidelberg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Site Status NOT_YET_RECRUITING

Universitätsklinikum Münster

Münster, , Germany

Site Status ACTIVE_NOT_RECRUITING

Evangelismos General Hospital

Athens, , Greece

Site Status RECRUITING

Laiko General hospital of Athens

Athens, , Greece

Site Status ACTIVE_NOT_RECRUITING

Policlinico di Sant'Orsola

Bologna, , Italy

Site Status ACTIVE_NOT_RECRUITING

ASST Spedali Civili di Brescia

Brescia, , Italy

Site Status RECRUITING

IRCCS Ospedale Policlinico San Martino

Genova, , Italy

Site Status RECRUITING

AOU Padova

Padua, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera "G. Brotzu"

Selargius, , Italy

Site Status NOT_YET_RECRUITING

Amsterdam UMC

Amsterdam, , Netherlands

Site Status RECRUITING

Radboud UMC

Nijmegen, , Netherlands

Site Status RECRUITING

Complejo Hospitalario Universitario de Vigo

Vigo, , Spain

Site Status WITHDRAWN

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status ACTIVE_NOT_RECRUITING

Skane University Hospital

Malmo, , Sweden

Site Status ACTIVE_NOT_RECRUITING

St Thomas' Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

St Mary's Hospital

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Austria Denmark Germany Greece Italy Netherlands Spain Sweden United Kingdom

Central Contacts

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Gabrielle Valle Diekmann

Role: CONTACT

+49 (0)174 690 0619

Daniele Frangioni

Role: CONTACT

+393427736782

Facility Contacts

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Florian Wolf, Prof

Role: primary

Timothy Resch, Prof

Role: primary

Philipp Schäfer, Prof

Role: primary

Theodoros Kratimenos, Dr

Role: primary

Luca Bertoglio, Prof

Role: primary

Giovanni Pratesi, Prof

Role: primary

Michele Antonello, Prof

Role: primary

Mario Dr Moro, Dr

Role: primary

Vincent Jongkind, Dr

Role: primary

Guillaume Geuzebroek, Dr

Role: primary

Said Abisi, Dr

Role: primary

Colin Bicknell, Dr

Role: primary

Other Identifiers

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TGR 23-02TB

Identifier Type: -

Identifier Source: org_study_id

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