Morges

Researchers are evaluating treatments for infrarenal abdominal aortic aneurysms (AAA) with wide proximal aortic neck diameters between 28mm and 32mm. The goal is to compare clinical outcomes between standard endovascular aneurysm repair (EVAR) using the Endurant II/IIs stent graft system and endosuture aneurysm repair (ESAR) which combines the Endurant II/IIs stent graft with the Heli-FX EndoAnchor system. This prospective, randomized controlled trial involves up to 300 subjects across about 40 sites in Europe and the US, focusing on gathering clinical evidence specific to this patient population where current comparative data are lacking. Participants will be randomly assigned in a 1:1 ratio to receive either EVAR alone or EVAR combined with the EndoAnchor system (ESAR). Treatments will follow the instructions for use of the Endurant II/IIs and Heli-FX EndoAnchor devices. Follow-up assessments will occur at baseline, the time of the procedure, 1 month, and then annually for up to 5 years. The trial aims to assess the superiority of ESAR over EVAR in terms of clinical outcomes related to the wide proximal neck anatomy. During the study, participants will undergo clinical evaluations and CT imaging according to local guidelines and device recommendations. Researchers will monitor treatment success, focusing on proximal seal outcomes over a one-year period as the primary measure. Safety and long-term effectiveness will also be tracked through yearly follow-ups for up to five years, providing comprehensive data on the performance of these treatments in managing infrarenal AAA with wide proximal necks.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.