Global Fenestrated Anaconda Clinical STudy

To be considered for this study, you would need to be 18 years old or older and be willing to follow all the study instructions and attend follow-up appointments. You also need to have an Abdominal Aortic Aneurysm (AAA) that is either 5.5cm or larger, or one that has grown by more than 1cm in the last year if it's currently 4.5cm or more. Importantly, your medical team and the device manufacturer would need to agree that your specific aneurysm is suitable for treatment with the Fenestrated Anaconda™ device.

However, there are several reasons why you might not be able to join. For example, if your doctor believes you have less than two years to live, or if you have certain medical conditions like an allergy to materials in the device (such as polyester or nickel), or a severe bleeding disorder. You also wouldn't be eligible if your aneurysm has already ruptured or is leaking, or if you've had a stroke or heart attack recently. Pregnancy and certain connective tissue diseases would also prevent participation, as would having a previous stent in your abdominal aorta. This is all to ensure the study is as safe and effective as possible for everyone involved.

If you were to take part in this study, you would receive the Fenestrated Anaconda™ Custom AAA Stent Graft System as your treatment for your Abdominal Aortic Aneurysm. The study doesn't involve any additional experimental drugs or procedures beyond your standard care with this device. You would be expected to attend follow-up appointments, which your doctor would arrange, to monitor your health and how the device is working. These appointments would involve regular check-ups and possibly scans. The study aims to collect information on both your short-term recovery and your long-term health, so follow-up could extend over several years. The exact number and timing of visits would be explained to you in detail by your medical team.