Zenith® TX2® Low Profile TAA Endovascular Graft

APPROVED_FOR_MARKETING

Conditions studied: Aortic Aneurysm, Penetrating Ulcer, Vascular Disease

In brief

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.

Key facts

Study ID

NCT02471781

Run by

Cook Group Incorporated

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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 — St 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

Full record on ClinicalTrials.gov

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