Zenith TX2® Post-market Approval Study

Completed · Not applicable

Conditions studied: Descending Thoracic Aortic Aneurysm

In brief

The Zenith TX2® Post-market Approval Study is a clinical trial approved by US FDA to further study the safety and effectiveness of the Zenith TX2® TAA Endovascular Graft in the treatment of thoracic aortic aneurysms.

Key facts

Study ID

NCT00813358

Run by

Cook Research Incorporated

People needed

115

Starts

2009-07-10

Expected to finish

2020-03-23

Last updated by the study team

2021-06-04

Who can join

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

You may qualify if…

• Descending thoracic aortic aneurysm with diameter greater than or equal to 5.0 cm; or
• Descending thoracic aortic aneurysm with a history of growth greater than or equal to 0.5 cm within the previous 12 months; or
• Descending thoracic aortic degenerative or atherosclerotic ulcers greater than or equal to 10 mm in depth and 20 mm in diameter

You may not qualify if…

• Age less than 18 years
• Other medical condition that may cause the patient to be non-compliant with the protocol, confound the results, or is associated with limited life expectancy (i.e., less than 2 years)
• Pregnant, breast-feeding, or planning on becoming pregnant within 24 months
• Unwilling or unable to comply with the follow-up schedule
• Inability or refusal to give informed consent
• Simultaneously participating in another investigative device or drug study

Where it is running

• Kaiser Permanente — San Francisco, California, United States
• University of Denver Colorado — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Heart Care Midwest — Peoria, Illinois, United States
• Iowa Heart Center — West Des Moines, Iowa, United States
• University of Massachusetts — Worcester, Massachusetts, United States
• University of Michigan Hospital — Ann Arbor, Michigan, 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 Hospital of Queens — Flushing, New York, United States
• North Shore University Hospital — Manhasset, New York, United States
• New York University — New York, New York, United States
• Strong Memorial Hospital — Rochester, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• DFW Vascular Group — Dallas, Texas, United States
• Baylor University Medical Center at Dallas — Dallas, Texas, United States
• The Heart Hospital Baylor Plano — Plano, Texas, United States
• University of Virginia Medical Center — Charlottesville, Virginia, United States
• Harborview Medical Center — Seattle, Washington, United States
• London Health Sciences Centre — London, Ontario, Canada

Full record on ClinicalTrials.gov

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