Study Comparing 3D-Printed Physician-Modified Stent-Grafts With Custom-Made Fenestrated Stent-Grafts For Complex Abdominal Aortic Aneurysms

What this Trial Is About

The trial investigates the comparison between physician-modified stent-grafts created using patient-specific 3D-printed aortic templates and commercially manufactured custom-made fenestrated stent-grafts for treating complex abdominal aortic aneurysms, including juxtarenal, pararenal, thoracoabdominal aneurysms, and type IA endoleak. This randomized, multicenter, open-label study aims to evaluate the efficacy and safety of these two approaches in patients with these specific aortic conditions. Participants will be randomly assigned to one of two groups Arm A will receive the innovative angiosurgery treatment with physician-modified stent-grafts guided by 3D-printed templates, and Arm B will receive the standard procedure involving implantation of custom-made fenestrated stent-grafts via an endovascular approach. The study includes a screening phase lasting up to 28 days, followed by two hospitalizations during which the angiosurgery interventions occur. After intervention, participants will have two follow-up visits, with safety monitoring continuing for 12 months. During the study, participants will undergo several assessments including aorta evaluation by angio CT at screening, during the first hospitalization, and at 30-day and 12-month follow-ups. Researchers will monitor survival rates at 30 days and 1 year without aortic rupture, along with other outcomes such as aneurysm growth, cardiovascular events, renal function changes, reintervention rates, and overall mortality. The study aims to gather detailed efficacy and safety data with a total follow-up period of one year post-procedure.

Evaluation of Clinical Efficacy and Safety of Aortal Stent-Graft Created Using 3D Printing Technology