International Study on Safety and Performance of the BeFlow Iliac Covered Stent System Monitoring Clinical Benefits and Side Effects of Iliac Artery Stenting

What this Trial Is About

This international, observational multi-centre study focuses on evaluating the safety, performance, and clinical benefit of the BeFlow Iliac Covered Stent System in patients with iliac artery stenosis or occlusion. The study aims to monitor the technical success of stent implantation, track clinical outcomes, and identify any potential unknown side effects related to the devices intended use. Participants will undergo endovascular treatment involving the permanent intraluminal placement of a covered stent in the iliac arteries to restore and improve blood flow. The study observes the devices performance over time without assigning experimental treatments, as it is an observational study involving real-world use of the stent. Throughout the study, participants will be monitored for various outcomes including the primary patency rate at 12 months, rates of stent-related complications, technical success, and changes in clinical classifications up to 60 months. Researchers will collect data on safety and effectiveness while following up for long-term results, with the study expected to conclude by the end of 2031.

An Observational Study to Evaluate Safety, Performance, and Clinical Benefit of BeFlow