Physician Initiated Trial Investigating ESAR and FEVAR for Treatment of Aortic Aneurysms With Short Infrarenal Neck

What this Trial Is About

Researchers are evaluating two types of endovascular treatments for abdominal aortic aneurysms with short aortic necks measuring between 4 to 15 millimeters. The study compares the safety and performance of Endovascular Aneurysm Repair with EndoAnchor system (ESAR) using Endurant plus Heli-FX EndoAnchor devices against Fenestrated Endovascular Aneurysm Repair (FEVAR) using customizable grafts from Cook and Terumo. This randomized trial is sponsored by the Foundation for Cardiovascular Research and Education and focuses on patients who are not candidates for standard EVAR due to challenging anatomy. Participants are randomly assigned to receive either the ESAR treatment, which combines the Endurant II or Endurant IIs endograft with the Heli-FX EndoAnchor system, or the FEVAR treatment, which uses fenestrated grafts such as the Cook Zenith Fenestrated Graft or Terumo Fenestrated Anaconda Graft. Both treatments involve implanting devices to repair the aneurysm by reinforcing the weakened aortic wall and ensuring better sealing in difficult anatomy cases. Treatments are performed as procedures guided by imaging, and patients are monitored over time to assess the outcomes. During the study, participants undergo evaluations including imaging and clinical assessments to measure technical success within 12 months after the procedure and monitor safety by tracking major adverse events within 30 days. Additional follow-ups occur at 1, 12, 24, and 36 months to assess factors such as artery patency, endoleaks, secondary interventions, aneurysm rupture, device migration, and sac size changes. The study also reviews procedure details like contrast volume and fluoroscopy time. Participants are followed for safety and effectiveness for up to three years after treatment.

ShOrt neCK AAA RAndomized Trial - ESAR and FEVAR: SOCRATES