Elk

Researchers are evaluating the use of the PERCUTEK Tycheseal21 stent-graft system for repairing abdominal aortic aneurysms (AAA) in a real-world setting across multiple centers in Italy and Poland. This observational registry study aims to collect detailed patient, procedural, and outcome data to assess the technical success, safety, and mid-term performance of this tri-modular endograft system. The study focuses on patients with infrarenal AAA, a condition where the abdominal aorta is abnormally enlarged and at risk of rupture, which can be life-threatening without timely treatment. The PERCUTEK Tycheseal21 system consists of a main body and two iliac limb components designed for precise placement and adaptability to challenging anatomical features such as varying neck diameters and angles. The device is delivered through a low-profile system and includes features to enhance visibility and durability. Throughout the study, participants will receive endovascular repair using this device, with data collected on procedure details and device performance. Follow-up assessments occur at discharge, 1 month, 12 months, and 24 months after implantation to monitor outcomes. Participants will undergo regular evaluations including imaging studies such as Doppler ultrasound and angio CT to monitor for complications like endoleaks, aneurysm sac changes, stent-graft migration, occlusion, or rupture. The study measures technical success defined by correct device deployment without immediate complications and tracks freedom from adverse events over 12 months. Data are entered into standardized forms and monitored for quality. The total enrollment is expected to be 120-200 patients over 18 months, with follow-up continuing up to 24 months post-implantation.