Zenith® TX2® Low Profile TAA Endovascular Graft
1 other identifier
expanded_access
N/A
1 country
15
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 15, 2015
CompletedJanuary 18, 2020
January 1, 2020
June 11, 2015
January 15, 2020
Conditions
Keywords
Interventions
Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
University of South Florida
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30322, United States
Methodist Hospital of Indiana
Indianapolis, Indiana, 46202, United States
Indiana Heart Hospital
Indianapolis, Indiana, 46250, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
The Mount Sinai Hospital
New York, New York, 10029, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Ohio State University
Columbus, Ohio, 43210, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl Illig, MD
Dialysis Access Center
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 15, 2015
Last Updated
January 18, 2020
Record last verified: 2020-01