TBE Zone 2 PMS in Japan
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorW.L.Gore & Associates
About this trial
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.
Eligibility criteria
Qualifiers
Those who are suitable for use of TBE according to the Japan package insert.
Thoracic aortic aneurysm,
Traumatic transection, and
Complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy.
Disqualifiers
N/A
Trial design
Treatments tested in this trial
- Gore® TAG® Thoracic Aortic Branch Stent Graft System
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
W.L.Gore & Associates
Lead sponsor
CMIC Co, Ltd. Japan
Collaborator
Source ClinicalTrials.gov