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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated
ClinicalTrials.gov Identifier:
NCT00813358
First received: December 19, 2008
Last updated: March 3, 2017
Last verified: March 2017
December 19, 2008
March 3, 2017
July 2009
October 2020   (Final data collection date for primary outcome measure)
Thoracic aortic aneurysm-related mortality [ Time Frame: 5 years ]
Same as current
Complete list of historical versions of study NCT00813358 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Zenith TX2® Post-market Approval Study
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Descending Thoracic Aortic Aneurysm
Device: Zenith TX2® TAA Endovascular Graft
Endovascular treatment with the study device
Other Name: TEVAR
Experimental: Endovascular repair
treatment
Intervention: Device: Zenith TX2® TAA Endovascular Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
115
October 2020
October 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
 
 
NCT00813358
08-005
370024, 2PAS
Not Provided
Not Provided
Not Provided
Cook Group Incorporated
Cook Group Incorporated
Not Provided
Not Provided
Cook Group Incorporated
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP