Zenith TX2® Post-market Approval Study



Status:Active, not recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:1/19/2019
Start Date:July 2009
End Date:October 2020

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Zenith TX2® TAA Endovascular Graft Post-approval Study

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
25
sites
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Tampa, FL
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3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Gainesville, Florida 32610
(352) 392-3261
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Gainesville, FL
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
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Manhasset, NY
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Philadelphia, PA
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Ann Arbor, Michigan 48109
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Ann Arbor, MI
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Aurora, Colorado 80045
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Aurora, CO
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1 Cooper Plaza
Camden, New Jersey 08103
(856) 342-2000
Cooper University Hospital Cooper University Health Care, the clinical campus of Cooper Medical School of...
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Camden, NJ
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Chapel Hill, North Carolina 27599
(919) 962-2211
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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Charlottesville, Virginia 22908
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Charlottesville, VA
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Dallas, TX
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Dallas, Texas 75208
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Dallas, TX
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Flushing, New York 11355
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Flushing, NY
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30 Prospect Ave
Hackensack, New Jersey 07601
(201) 996-2000
Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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Hackensack, NJ
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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London,
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70 Washington Square S
New York, New York 10012
(212) 998-1212
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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New York, NY
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Peoria, Illinois 61614
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Peoria, IL
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Pittsburgh, PA
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Plano, Texas 75093
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Plano, TX
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Rochester, New York 14642
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Rochester, NY
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San Francisco, California 94115
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San Francisco, CA
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Seattle, WA
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West Des Moines, Iowa 50266
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West Des Moines, IA
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Worcester, Massachusetts 01655
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Worcester, MA
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