The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collectconfirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA EndovascularGraft is indicated for the treatment of patients with a descending thoracic aorticaneurysm or penetrating ulcer and has an anatomy suitable for repair.
Device: Zenith TX2 Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic
aorta having morphology suitable for endovascular repair.
Other Name: Zenith Alpha Thoracic™ Endovascular Graft
Inclusion Criteria:
- Meets one of the following
- Descending thoracic aneurysm with diameter ≥ 5.0 cm
- Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year
- Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and
20 mm in diameter
Exclusion Criteria:
- Life expectancy less than 2 years
- Pregnant of breastfeeding or planning on becoming pregnant within 60 months
- Unwilling to comply with the follow-up schedule
- Less than 30 days beyond primary endpoint for other investigative drug or device
study
- Receiving home oxygen
- Myocardial infarction within the last 3 months
- Stroke within the last 3 months
- Diagnosed or suspected congenital degenerative collagen disease
- Systemic infection
- Bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion
- Allergy to polyester, polypropylene, nitinol, or gold
- Previous placement of a thoracic endovascular graft
- Prior open repair involving the descending thoracic aorta
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, United States
Indiana Heart Hospital
Indianapolis, Indiana, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Barnes-Jewish Hospital
Saint Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper University Hospital
Camden, New Jersey, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
The Mount Sinai Hospital
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Karl Illig, MD, Principal Investigator
Dialysis Access Center