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NCT Number: NCT07742592

Retrospective Real-World Data Collection of the Conformable GORE® TAG® Thoracic Endoprosthesis When Used in Frozen Elephant Trunk Procedures for Treatment of Aortic Aneurysms and Dissections

Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure

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Key information

About this study

Retrospective, multicenter, single-arm registry data collection designed to characterize outcomes in patients treated with the Conformable GORE® TAG® Thoracic Endoprosthesis deployed in an antegrade fashion as part of a frozen elephant trunk (FET) procedure and to assess the safety and performance of the Conformable GORE® TAG® Thoracic Endoprosthesis deployed antegrade as part of a FET procedure. This will be evaluated using real-world data and Computed Tomography (CT) imaging abstracted through retrospective chart review.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Treated for aneurysm or dissection using antegrade deployed Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device at least 12 months prior to date of enrollment.
  • Age ≥ 18 years at the time of the index procedure.
  • Proximal extent of the Conformable GORE® TAG® Thoracic Endoprosthesis (CTAG) device is sutured to the aorta and/or distal aspect of the surgical graft.
  • Informed Consent Form (ICF) is signed by the subject or a legally authorized representative, or a waiver of consent is granted by the IRB of record and appropriately documented by the enrolling site.

Exclusion criteria

  • Any modification performed on the CTAG Device, excluding suturing.
  • Procedure performed in the setting of infection requiring treatment with parenteral anti-infective medication.
  • Pregnant at the time of the index procedure.
  • Aneurysm or Subacute / Chronic Dissection cases (onset of symptoms ≥15 days prior to the date of the procedure) with documented aortic rupture at the time of the index procedure.

Treatment and study plan

Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure

Device

Antegrade deployment of covered thoracic aortic stent graft as completion in frozen elephant trunk procedure

Primary outcomes

  1. MAE freedom within one year (365 days) post-implant

    Time frame: From date of index procedure through 365 days post implant

    The primary endpoint will be measured as freedom from the composite of the following major adverse events (MAE) occurring within one year (365 days) post-implant:

    • Permanent Stroke
    • Permanent Paraplegia/ Paraparesis
    • Mortality
    • Reoperation

Secondary outcomes

  1. Freedom from imaging outcomes within the 12-Month analysis window

    Time frame: From the date of the index procedure through end of 12 months analysis window unless otherwise specified

    The secondary endpoints will be measured as freedom from each of the following imaging outcomes within the 12-Month analysis window unless specified:

    • Failed Patency (within one year (365 days) post-implant)
    • Pseudoaneurysm (within one year (365 days) post-implant)
    • Increase in Aortic Diameter
    • Device Integrity
    • Device Migration
    • Type IA Endoleak
    • Type IB Endoleak
    • Type III Endoleak
    • Thrombosis of Index Pathology

Study contacts

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

Harrison Lead Clinical Study Manager

CONTACT

[email protected]

12068225653

Sponsors and collaborators

Lead sponsor

W.L.Gore & Associates

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

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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