Testing custom-modified grafts for complex aortic artery disease

This trial is testing a treatment approach called physician-modified endovascular grafts (PMEGs) for people with serious aortic disease that is too complex for standard repair options. Instead of open surgery, which carries high risk, surgeons customize an approved graft device to fit each patient's unique anatomy and insert it through blood vessels. This treatment aims to help high-risk patients who cannot wait for custom-made devices or don't qualify for existing approved options.

Many patients with complex aortic disease cannot safely undergo traditional open surgery due to serious health conditions, and there is only one FDA-approved custom device available — which takes time to manufacture and doesn't work for all patients. This trial exists to prove that the medication approach of modifying standard grafts can be a safe and effective solution for these patients who currently have few options.