Status:
COMPLETED
STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
Lead Sponsor:
Cook Group Incorporated
Collaborating Sponsors:
William Cook Europe
William Cook Australia
Conditions:
Thoracic Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Dru...
Detailed Description
The STARZ-TX2 trial (Study of Thoracic Aortic Aneurysm Repair with the Zenith TX2(R) TAA Endovascular Graft) is a clinical trial approved by the FDA to study the safety and effectiveness of the Zenith...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.)
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT00111176
Start Date
March 1 2004
End Date
May 1 2013
Last Update
August 18 2014
Active Locations (41)
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1
Banner Desert Medical Center
Mesa, Arizona, United States, 85202
2
Arizona Heart Institute
Phoenix, Arizona, United States, 85006
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Stanford University Hospital and Clinics
Stanford, California, United States, 94305