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

SexALL

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

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

Serious Device-related Ischemia

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