Evaluating the Safety and Effectiveness of the iCover Covered Stent as a Bridging Stent in Fenestrated Endovascular Aortic Repair for Complex Abdominal Aortic Aneurysms

What this Trial Is About

Researchers are evaluating the use of the iCover balloon-expandable covered stent as a bridging stent in fenestrated endovascular aortic repair fEVAR to treat complex abdominal aortic aneurysms. This European multicenter, prospective study aims to demonstrate the safety and performance of iCover when implanted in target vessels during fEVAR procedures, which are preferred for their benefits over open surgery, such as reduced renal dysfunction risk and faster recovery. Participants will receive the iCover stent implanted as a bridging stent during the fEVAR procedure. The iCover stent is designed to be placed in renal and visceral arteries with specific size and anatomical requirements. The study includes a treatment phase where the device is implanted, followed by regular follow-up visits at discharge, 6 months, and 12 months to monitor the stents patency, stability, and absence of complications like endoleaks or aneurysm growth. During the study, participants will undergo imaging tests such as CT angiography and other evaluations to assess stent function and aneurysm status at specified intervals. Researchers will track outcomes including stent patency, vessel stability, technical success of implantation, and any adverse events or mortality up to 12 months post-implant. Participants are expected to attend all follow-up visits and comply with study procedures over the course of approximately one year.

Clinical Performance and Safety Assessment of the Use of iCover Balloon Expandable Covered Stent (iVascular) Implanted as Bridging Stent in FEVAR (Fenestrated Endovascular Aortic Repair) for the Treatment of Complex Abdominal Aortic Aneurysms