Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study

Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption (IDE) Study

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA).

A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm (AAA). The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system. The study will have up to 16 sites, and up to 75 patients based on attrition rates. The follow-up intervals will be at 1, 6, and 12 months following initial implant procedure.

Inclusion Criteria include:

1. Patient has adequate iliac/femoral access compatible with the required delivery systems.
2. Patient has non-aneurysmal proximal aortic neck.
3. Patient has non-aneurysmal distal iliac landing zone.

Exclusion Criteria include:

1. Patient has dissecting aneurysm.
2. Patient has acutely ruptured aneurysm.
3. Patient has need for emergent surgery.