Real-World Registry of PERCUTEK Tycheseal Tri-Modular Stent-Graft System for Endovascular Repair of Abdominal Aortic Aneurysm

What this Trial Is About

Researchers are collecting and analyzing real-world data from multiple centers in Italy and Poland on the use of the PERCUTEK Tycheseal stent-graft system for repairing abdominal aortic aneurysms AAA. The study aims to evaluate the technical success, safety, and mid-term outcomes of this device in actual clinical practice. It focuses on patients with suitable anatomy undergoing this procedure, to provide evidence on the devices performance and related complications over time. This is an observational, physician-initiated registry enrolling 120 to 200 patients over about 18 months. Participants receive the PERCUTEK Tycheseal tri-modular endograft system, which includes a main body and two iliac limbs designed to fit a range of aortic anatomies. The device features a low-profile delivery system and radiopaque markers to aid placement. Data on the procedure and outcomes are collected without experimental treatments or randomization. Participants are followed for up to 24 months after device implantation with assessments at baseline, discharge, 1 month, 12 months, and 24 months. Study measures include technical success defined by proper device positioning and no immediate serious leaks, aneurysm size changes, endoleak presence, device migration or occlusion, and major adverse events. Data are collected using standardized forms, and safety outcomes are monitored throughout the study period to understand the devices mid-term clinical performance.

Poland-Italy Aortic Research Bridge Real World Registry