STARZ-TX2 Clinical Study: Study of Thoracic Aortic Aneurysm Repair With the Zenith TX2 Endovascular Graft
NCT ID: NCT00111176
Last Updated: 2014-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
260 participants
INTERVENTIONAL
2004-03-31
2013-05-31
Brief Summary
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Detailed Description
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The Zenith TX2 TAA Endovascular Graft is a reinforced fabric tube that is sized to the length of the aorta that needs to be covered to seal off the aneurysm / ulcer. The graft is made of a polyester material like that used in open surgical repair. Standard surgical suture is used to sew the graft material to a frame of self-expanding stainless steel stents, which provide support. The materials used in the Zenith TX2 system have a long history of use in medical implants.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Endovascular Repair
Endovascular repair
Endovascular repair.
2
Surgical
Surgical
Surgical endovascular repair
Interventions
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Endovascular repair
Endovascular repair.
Surgical
Surgical endovascular repair
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients who are candidates for either surgery or endovascular repair
* Patients at least 18 years old
Exclusion Criteria
* 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.)
18 Years
ALL
No
Sponsors
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William Cook Europe
INDUSTRY
William Cook Australia
INDUSTRY
MED Institute, Incorporated
INDUSTRY
Cook Group Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Jon Matsumura, MD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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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
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
MeritCare
Fargo, North Dakota, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Riverside Methodist Hospital
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, United States
Peter Lougheed Center
Calgary, Alberta, Canada
Vancouver Hospital and Health Science Center
Vancouver, British Columbia, Canada
San Raffaele Hospital
Milan, , Italy
Countries
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References
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Matsumura JS, Melissano G, Cambria RP, Dake MD, Mehta S, Svensson LG, Moore RD; Zenith TX2 Clinical Trial Investigators. Five-year results of thoracic endovascular aortic repair with the Zenith TX2. J Vasc Surg. 2014 Jul;60(1):1-10. doi: 10.1016/j.jvs.2014.01.043. Epub 2014 Mar 14.
Other Identifiers
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37010
Identifier Type: -
Identifier Source: secondary_id
03-536
Identifier Type: -
Identifier Source: org_study_id
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