Zenith® TX2® Low Profile TAA Endovascular Graft
- Conditions
- Aortic AneurysmPenetrating UlcerVascular Disease
- Registration Number
- NCT02471781
- Lead Sponsor
- Cook Group Incorporated
- Brief Summary
The Zenith TX2 Low Profile TAA Endovascular Graft extended study is to collect confirmatory safety and effectiveness data. The Zenith TX2 Low Profile TAA Endovascular Graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
-
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
- 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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (15)
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
Scroll for more (5 remaining)University of South Florida🇺🇸Tampa, Florida, United States