Status: No Longer Enrolling
Do you have an infrarenal abdominal aortic aneurysm?
If you have an infrarenal abdominal aortic aneurysm, this study may be an option for you.
The primary goal of this study is to gather safety and effectiveness data on the Treovance Strent-Graft device in subjects with abdominal aortic aneurysms.
Candidates for Infrarenal Abdominal Aortic Aneurysm Study
You may qualify for this study if you:
- Subject must be diagnosed with an infrarenal abdominal aortic aneurysm (AAA), with or without iliac artery involvement
- Subject must have an infrarenal AAA that is > 4.5 cm in diameter for males, or > 4.0 cm in diameter for females, or has increased in diameter by 0.5 cm in the last 6 months
Study Length & Information: This is a phase II, multi-center, non-blinded, non-randomized study of treatment with the Treovance Stent-Graft in subjects with abdominal aortic aneurysms. The study will include 150 subjects treated with the Treovance Stent-Graft at a maximum of 30 investigational sites. There will be no prospective control group. Subjects diagnosed with infrarenal abdominal aortic aneurysms enrolled in the trial will be treated with the Treovance Stent-Graft with Navitel Delivery System. Pre-procedure baseline data will be gathered, as well as post-procedure assessments prior to hospital discharge and 30 days, 6 months, and 12 months post-implantation. In addition, annual follow-up visits out to 5 years will be conducted.
Principal Investigator: Jeffrey M. Slaiby, MD, FACS, RPVI