TBE stent-graft repair for thoracic aortic disease with Zone 2 proximal landing in Japan

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a post-marketing observational surveillance using the GORE TAG Thoracic Branch Stent Graft System to confirm safety and effectiveness when the device is landed proximally in aortic Zone 2. Patients are enrolled if they meet the Japan package insert anatomical requirements for preserving left subclavian artery blood flow, including thoracic aortic aneurysm, traumatic transection, or complicated Stanford type B dissection not controlled by medical therapy. Treatments follow routine clinical care at participating centers and outcomes and adverse events are collected during follow-up. The registry-style design is non-randomized and intended to capture real-world device performance in the post-marketing period.

Why it matters

Who can join: the full rules

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

Where it's running

• The University of Osaka Hospital
  Osaka, Suita, Japan Recruiting

Study contacts

• Study coordinator: Hideyuki Saigusa
• Email: hsaigusa@wlgore.com
• Phone: 819039126169

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.