Study of Endovascular Aortic Repair With Coil Embolization to Prevent Type II Endoleaks in Patients with Abdominal Aortic Aneurysm

What this Trial Is About

Researchers are investigating a procedure to prevent type II endoleaks T2EL in patients undergoing endovascular aortic aneurysm repair EVAR for abdominal aortic aneurysms AAA. T2EL occurs when blood flows persistently into the aneurysm sac due to reversed blood flow in small vessels, potentially causing aneurysm growth or rupture. This study aims to evaluate whether adding coil embolization to the aneurysm sac during EVAR can reduce the risk of T2EL, which is associated with complications and difficult secondary treatments. Participants are randomly assigned to one of two groups one receiving standard EVAR alone and the other receiving EVAR with additional coil embolization of the aneurysm sac. The coil embolization involves deploying metal coils inside the aneurysm sac during the EVAR procedure to block vessels that may cause T2EL. The type of coils used is not predefined. This controlled study compares outcomes between these two approaches to determine the benefit of sac embolization. During the study, participants will be monitored for the presence of type II endoleaks at multiple time points, including days 2 to 4, 30 days, 6 months, and 12 months after the procedure. Researchers will also track other outcomes such as the need for re-intervention, aneurysm morphology, rupture, mortality, and quality of life over 12 months. The main outcome measure is the presence of T2EL at 12 months. Total study participation can last up to about 12 months with follow-up assessments to evaluate the effectiveness and safety of the treatment approaches.

EndoVascular Aortic Repair With Sac Embolization for the Prevention of Type II Endoleaks (the EVAR-SE Study)