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

This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00813358
First received: December 19, 2008
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention
Descending Thoracic Aortic Aneurysm
 Device: Zenith TX2® TAA Endovascular Graft

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zenith TX2® TAA Endovascular Graft Post-approval Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Thoracic aortic aneurysm-related mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 115
Study Start Date: July 2009
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular repair
treatment
 Device: Zenith TX2® TAA Endovascular Graft
Endovascular treatment with the study device
Other Name: TEVAR

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813358

Contacts
Contact: Manjula Menon 765-463-7537 mmenon@medinst.com

  Show 23 Study Locations
Sponsors and Collaborators
Cook
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00813358     History of Changes
Other Study ID Numbers: 08-005, 370024, 2PAS
Study First Received: December 19, 2008
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
Endovascular Aneurysm Repair
Aortic Aneurysm
Thoracic

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

ClinicalTrials.gov processed this record on June 17, 2013