SEAL - Safety & Feasibility Evaluation of the Aortoseal™ for Seal and Fixation of Abdominal Aortic Aneurysms (AAA) Endovascular Grafts to the Aortic Wall"
Endoron Medical
Summary
The Aortoseal Endostapling System is indicated in patients undergoing, or having undergone, treatment of an abdominal aortic aneurysm (AAA) with an endovascular graft to provide enhanced fixation and apposition to the aorta.
Description
The device may be implanted at the time of the initial endovascular graft procedure to maintain, or during a secondary procedure to restore, adequate aneurysm. The study includes 5 years of follow-up, with visits at 30 days, 6 months, 1 year, and yearly thereafter through 5-years. Follow-up assessments: Physical examination, X-ray, CT (with and without contrast) and assessments of any adverse events.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Subjects diagnosed with a qualifying AAA suitable for elective endovascular repair with Endovascular Graft System or have a previously placed endovascular graft.
Interventions
- DeviceAortoseal Endostapling System
Aortoseal Endostapling System
Location
- Sentara Health Research CenterNorfolk, Virginia