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Not yet recruiting NCT07691931

TBE Zone 0/1 PMS in Japan

— Observational Aneurysm of Aorta, Thoracic Dissection of Aorta, Thoracic Trauma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gore® TAG® Thoracic Aortic Branch Stent Graft System.
Who it may be relevant to
Registry conditions: Aneurysm of Aorta, Thoracic, Dissection of Aorta, Thoracic, Trauma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 Post-Market Surveillance in Japan

Overview

The goal of this surveillance is to confirm the safety and efficacy of TBE under actual use in the Zone 0/1 lesion on post-marketing usage conditions.

Interventions

  • Device Gore® TAG® Thoracic Aortic Branch Stent Graft System
    Patients who attempted implant of TBE in Zone 0/1 during the enrollment period for each indication (including patients in whom TBE is not placed in Zone 0/1 area).

Primary outcome measures

  • Device Technical Success at the Initial Endovascular Procedure [Time frame: TBE Initial Implant Procedure]
  • Lesion-related Mortality and All-cause Death [Time frame: 60 Months]
  • Aortic Rupture of the Treatment Lesion [Time frame: 60 Months]
  • Disabling Stroke [Time frame: 60 Months]
  • Serious Paraplegia [Time frame: 60 Months]
  • Serious Paraparesis [Time frame: 60 Months]
  • Renal Failure Requiring Dialysis [Time frame: 60 Months]
  • Additional Unanticipated Post-procedural Reintervention [Time frame: 60 Months]
  • Serious Device-related Ischemia [Time frame: 60 Months]
  • Distal Device-related Thromboembolic Serious Adverse Event Requiring Intervention or Surgery [Time frame: 60 Months]

Eligibility criteria

Inclusion criteria

Those who are suitable for use of TBE according to the Japan package insert. \[Reference: Purpose of Use or Effects of TBE at the time of launch\] The GORE® TAG® Thoracic Branch Endoprosthesis is intended for use in patients with the following diseases of the aortic arch and descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to a single aortic arch target branch vessel.

  • Thoracic aortic aneurysm
  • Traumatic transection
  • Complicated Stanford type A (after surgical repair) and B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy

The GORE® TAG® Thoracic Branch Endoprosthesis may be used in combination with designated stent grafts with validated efficacy and safety.

Exclusion criteria

N/A

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07691931 · JPS 25-10

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗