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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 : March 6, 2017
Sponsor:
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
treatment
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
Criteria

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


  Show 25 Study Locations
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: March 6, 2017
Last Verified: March 2017

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

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