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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00813358
First received: December 19, 2008
Last updated: March 6, 2014
Last verified: March 2014

December 19, 2008
March 6, 2014
July 2009
March 2019   (final data collection date for primary outcome measure)
Thoracic aortic aneurysm-related mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
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
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
115
March 2019
March 2019   (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
Both
18 Years and older
No
Contact: Jennifer Gilmore 765-463-7537 jgilmore@medinst.com
United States,   Canada
 
NCT00813358
08-005, 370024, 2PAS
Not Provided
Cook
Cook
Not Provided
Not Provided
Cook
March 2014

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