Study Comparing Endosuture Aneurysm Repair and Standard Endovascular Repair for Abdominal Aortic Aneurysms with Wide Proximal Neck Using Endurant IIIIs and Heli-FX EndoAnchor Systems

What this Trial Is About

Researchers are evaluating treatments for infrarenal abdominal aortic aneurysm AAA with wide proximal aortic neck diameters 28mm to 32mm. The trial compares clinical outcomes of two methods endosuture aneurysm repair ESAR and standard endovascular aneurysm repair EVAR. This randomized controlled trial aims to provide clinical evidence about the effectiveness of these approaches in patients with this specific aneurysm anatomy, addressing a current lack of comparative data. The study involves two groups one receiving EVAR using the Endurant IIIIs stent graft system alone, and the other receiving ESAR with the Endurant IIIIs stent graft plus the Heli-FX EndoAnchor system. Up to 300 participants will be enrolled across multiple sites in Europe and the US. Participants will be followed according to recommended guidelines and device instructions, with assessments at baseline, the procedure, 1 month, and annually for up to 5 years. During the study, participants will undergo clinical evaluations including CT imaging and other assessments at scheduled visits. Researchers will measure outcomes such as the composite proximal seal success at 1 year, freedom from type IA endoleak, migration, aneurysm sac growth, and neck dilatation. Safety and long-term effectiveness will be monitored through these follow-ups, providing detailed information about the treatments over time.

Comparison of EVAR and ESAR for Infrarenal Aortic Aneurysms With a Wide Proximal Neck