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Zenith TX2® Post-market Approval Study (TX2 2PAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00813358
Recruitment Status : Active, not recruiting
First Posted : December 23, 2008
Last Update Posted : February 27, 2018
Information provided by (Responsible Party):
Cook Group Incorporated

Brief Summary:
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.

Condition or disease Intervention/treatment
Descending Thoracic Aortic Aneurysm Device: Zenith TX2® TAA Endovascular Graft

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenith TX2® TAA Endovascular Graft Post-approval Study
Study Start Date : July 2009
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Endovascular repair
Device: Zenith TX2® TAA Endovascular Graft
Endovascular treatment with the study device
Other Name: TEVAR

Primary Outcome Measures :
  1. Thoracic aortic aneurysm-related mortality [ Time Frame: 5 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00813358

  Hide Study Locations
United States, California
Kaiser Permanente
San Francisco, California, United States, 94115
United States, Colorado
University of Denver Colorado
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Tampa General Hospital
Tampa, Florida, United States, 33601
United States, Illinois
Heart Care Midwest
Peoria, Illinois, United States, 61614
United States, Iowa
Iowa Heart Center
West Des Moines, Iowa, United States, 50266
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Hospital
Ann Arbor, Michigan, United States, 48109
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper University Hospital
Camden, New Jersey, United States, 08103
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
New York Hospital of Queens
Flushing, New York, United States, 11355
North Shore University Hospital
Manhasset, New York, United States, 11030
New York University
New York, New York, United States, 10016
Strong Memorial Hospital
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
DFW Vascular Group
Dallas, Texas, United States, 75208
Baylor University Medical Center at Dallas
Dallas, Texas, United States, 75226
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia Medical Center
Charlottesville, Virginia, United States, 22908
United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 5W9
Sponsors and Collaborators
Cook Group Incorporated

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00813358     History of Changes
Other Study ID Numbers: 08-005
370024, 2PAS
First Posted: December 23, 2008    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018

Keywords provided by Cook Group Incorporated:
Endovascular Aneurysm Repair
Aortic Aneurysm

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Thoracic
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases