Study of Allay Aortic Stent to Support Thoracic Endovascular Repair for Type B Aortic Dissection

What this Trial Is About

This research aims to evaluate the effectiveness and safety of the Allay4 Aortic Stent as an additional endovascular treatment for patients with Type B aortic dissection who are eligible for thoracic endovascular aortic repair using stent grafts. The study focuses on reducing late complications such as aortic growth requiring reintervention or rupture. It is a prospective, multicenter, open-label clinical trial designed to assess this investigational device alongside standard care. The treatment involves first placing a covered thoracic stent graft in the descending thoracic aorta above the celiac trunk, following standard care procedures. Subsequently, the Allay4 Aortic Stent is implanted from within the stent graft and extends below the celiac trunk to the end of the dissected aorta, usually reaching the aortoiliac bifurcation. This combined approach aims to improve outcomes for patients undergoing thoracic endovascular repair. Participants will undergo assessments including imaging by CT scans at various time points up to 60 months to evaluate aortic growth, device performance, and adverse events. Researchers will monitor freedom from aortic growth requiring reintervention or rupture at 12 months as the primary outcome, along with major adverse events within 30 days post-implantation. Long-term follow-up visits will assess mortality, reintervention, device patency, and complications, with participant involvement lasting several years for comprehensive safety and effectiveness monitoring.

EXtensive mulTilayer stEnt treatmeNt in Aortic disSectiOn