IRB Study Number 21-954
Status Recruiting
Phase Not Applicable
Institute Heart and Vascular Institute
Description
We invite you to take part in a research study because you have an abdominal aortic aneurysm. An abdominal aortic aneurysm (AAA) is a bulge in the aorta (the main artery leaving the heart) caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow and possibly rupture (break open), causing serious internal bleeding. // The purpose of this study is to evaluate the ongoing safety and effectiveness of the Alto™ Abdominal Stent Graft System in a real-world environment compared to other commercially available, FDA approved devices (Cook Zenith® System, Gore Excluder® System, Medtronic Endurant™ System). This study will collect data on your condition and the endovascular devices. The information collected from this study will be used to judge how well subjects do when treated for AAA during the procedure, after the procedure and over the following 5-years. No matter what device is implanted, you will have a minimally invasive EVAR procedure.
Inclusion Criteria
Subjects with non-ruptured infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
Adult age 21 or older.
Subjects with minimum of 2 year life expectancy.
Exclusion Criteria
Known connective tissue disorders.
Subjects with pre-existing EVAR, i.e., in need of repair/intervention of a previouslyfailed EVAR
