AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion

To join this study, you would need to be at least 18 years old and be a good candidate for the usual EVAR operation for an abdominal aortic aneurysm. Your aneurysm would need to be a certain size – at least 5.5cm for men and 5.0cm for women. Doctors would also check that the aneurysm isn't too solid with blood clots and has a big enough open space inside it.

There are also reasons why you might not be able to join. For example, if you can't give your clear permission to take part, or if you're already in another study that might affect the results of this one. Certain other medical conditions, like some problems with blood vessel access or specific types of aneurysms (like those that have burst or are infected), would also mean you couldn't participate. Also, if you need a type of EVAR device that isn't being tested in this study, you wouldn't be able to join.

The study aims to see how safe and effective the IMPEDE-FX RapidFill treatment is when added to your planned EVAR procedure. You would undergo the EVAR operation as planned, with the additional material inserted at the same time. After your procedure, you would have regular follow-up visits with the study team. These visits will involve checks to see how you are recovering and how the aneurysm is responding to the treatment. This will likely involve scans to measure your aneurysm and discussions about your general health. The exact number and timing of visits will be explained in detail, but they are crucial for monitoring your progress and collecting important information for the study.