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

Imagine the main blood vessel in your body, called the aorta, running from your heart down through your tummy. Sometimes, a section of this vessel can become weak and expand like a balloon – this is called an aneurysm. If this happens in your tummy, it's an abdominal aortic aneurysm. If it's particularly tricky or close to important blood vessels that go to your kidneys or other organs, we call it a complex abdominal aortic aneurysm.

Traditionally, fixing this might involve major open surgery. However, there's a less invasive way called fEVAR (fenestrated endovascular aortic repair). This involves using a thin tube (catheter) to insert a special fabric-covered tube (stent graft) into your aorta through a small cut, usually in your groin. This stent graft strengthens the weak area. The "fenestrated" part means the graft has custom-made holes (fenestrations) that line up with your important side blood vessels, like those going to your kidneys.

This study is testing a specific type of bridging stent called iCover. During the fEVAR procedure, these small iCover stents are used as a "bridge" to connect the main stent graft securely into those side blood vessels. This ensures good blood flow to your organs while keeping the aneurysm protected. The main goal of this study is to see how safe and effective the iCover stent is when used in this way, potentially offering a better and safer option for repairing complex abdominal aortic aneurysms.