TX2® Low Profile TAA Endovascular Graft

Completed · Not applicable

Conditions studied: Aortic Aneurysm, Penetrating Ulcer, Vascular Disease

In brief

The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.

Key facts

Study ID

NCT01151020

Run by

Cook Research Incorporated

People needed

110

Starts

2010-03-01

Expected to finish

2018-05-11

Last updated by the study team

2021-01-22

Who can join

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

You may qualify if…

• 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…

• Less than 18 years of age
• Life expectancy less than 2 years
• Pregnant or breastfeeding or planning on becoming pregnant within 60 months
• Unwilling to comply with the follow-up schedule
• Inability or refusal to give informed consent
• Less than 30 days beyond primary endpoint for other investigative drug or device study

Where it is running

• Kaiser Permanente — San Francisco, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• 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 — Ann Arbor, Michigan, United States
• Mayo Clinic Rochester — 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
• New York University Hospital — New York, New York, United States
• 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
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Tennessee Baptist Memorial Hospital — Memphis, Tennessee, United States
• Inova Fairfax Hospital — Falls Church, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States
• Hannover Medical School — Hanover, Germany
• St. Franziskus Hospital — Münster, Germany
• Klinikum Nürnberg Sud — Nuremberg, Germany

Full record on ClinicalTrials.gov

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