Post-Market Surveillance of Gore TAG Thoracic Branch Endoprosthesis Device for Zone 2 Aortic Conditions in Japan

What this Trial Is About

Researchers are conducting a post-market surveillance study to confirm the safety and effectiveness of the Gore4 TAG4 Thoracic Branch Endoprosthesis TBE device in patients treated with proximal landing in Zone 2 of the thoracic aorta. This observational study focuses on patients with descending thoracic aortic lesions, including thoracic aortic aneurysm, traumatic transection, and complicated Stanford type B aortic dissection that has not improved with medical therapy. The study aims to monitor outcomes over a long period following commercial use of the device in Japan. The study evaluates patients who have had the TBE device implanted in Zone 2 during the enrollment period according to the Japan package insert indications. The treatment involves the use of this specific thoracic aortic branch stent graft system designed to maintain blood flow to the left subclavian artery while addressing the targeted aortic lesions. This surveillance does not involve randomization or a control group, focusing instead on real-world outcomes after device implantation. Participants will be followed and monitored for up to 60 months after their initial procedure. Researchers will assess many outcomes including technical success of the device placement, aortic rupture at the treated site, overall and lesion-related mortality, stroke, paraplegia, renal failure requiring dialysis, serious adverse events related to device ischemia or thromboembolism, device integrity, and complications such as endoleak or aortic enlargement. The study will also evaluate specific dissection-related conditions in patients with aortic dissection. This comprehensive follow-up includes clinical evaluations, imaging, and safety monitoring throughout the post-procedural period.

TBE Zone 2 PMS in Japan