RecruitingNot Applicable

TBE Zone 2 PMS in Japan

Japan200 participantsStarted 2025-12-15

Plain-language summary

The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 with descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to the left subclavian artery. * Thoracic aortic aneurysm, * Traumatic transection, and * Complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy. Exclusion Criteria: * N/A

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Device Technical Success at the Initial Procedure

Timeframe: Initial procedure

Aortic Rupture of the Treatment Lesion

Timeframe: 60 Months

Lesion-related Mortality and All-cause Death

Timeframe: 60 Months

Disable Stroke

Timeframe: 60 Months

Serious Paraplegia

Timeframe: 60 Months

Serious Paraparesis

Timeframe: 60 Months

Renal Failure Requiring Dialysis

Timeframe: 60 Months

Additional Unanticipated Post-procedural Surgical or Interventional Procedure

Timeframe: 60 Months

Trial details

NCT IDNCT07049913

SponsorW.L.Gore & Associates

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2034-02

Contact for this trial

Hideyuki Saigusa

819039126169 hsaigusa@wlgore.com

View on ClinicalTrials.gov More Aneurysm Thoracic trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Device Technical Success at the Initial Procedure

Timeframe: Initial procedure

Aortic Rupture of the Treatment Lesion

Timeframe: 60 Months

Lesion-related Mortality and All-cause Death

Timeframe: 60 Months

Disable Stroke

Timeframe: 60 Months

Serious Paraplegia

Timeframe: 60 Months

Serious Paraparesis

Timeframe: 60 Months

Renal Failure Requiring Dialysis

Timeframe: 60 Months

Additional Unanticipated Post-procedural Surgical or Interventional Procedure

Timeframe: 60 Months