STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft

Completed · Not applicable

Conditions studied: Thoracic Aortic Aneurysm

In brief

The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA \[Thoracic Aortic Aneurysm\] Endovascular Graft) is a clinical trial approved by the United States Food and Drug Administration (FDA) to study the safety and effectiveness of the Zenith TX2 TAA Endovascular Graft in the treatment of thoracic aortic aneurysms / ulcers.

Key facts

Study ID

NCT00111176

Run by

Cook Group Incorporated

People needed

260

Starts

2004-03-01

Expected to finish

2013-05-01

Last updated by the study team

2014-08-18

Who can join

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

You may qualify if…

• Patients diagnosed with aneurysms / ulcers of the descending thoracic aorta
• Patients who are candidates for either surgery or endovascular repair
• Patients at least 18 years old

You may not qualify if…

• Age < 18 years
• Patients with other medical condition (e.g., cancer, congestive heart failure) that may cause non-compliance with the protocol, confound the results, or with limited life expectancy (i.e., less than 2 years)
• Patients pregnant, breast-feeding, or planning on becoming pregnant within 24 months
• Patients unwilling or unable to comply with the follow-up schedule
• Patients unable or who refuse to give informed consent
• Patients simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)

Where it is running

• Banner Desert Medical Center — Mesa, Arizona, United States
• Arizona Heart Institute — Phoenix, Arizona, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University Hospital and Clinics — Stanford, California, United States
• Swedish Medical Center — Englewood, Colorado, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• St. Vincent Hospital — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• University of Maryland Medical Center — Baltimore, Maryland, United States
• Union Memorial Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Albany Medical Center — Albany, New York, United States
• New York University Hospital — New York, New York, United States
• Lenox Hill Hospital — New York, New York, United States
• New York Presbyterian - Cornell — New York, New York, United States
• New York Presbyterian Hospital - Columbia — New York, New York, United States
• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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