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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00813358
First received: December 19, 2008
Last updated: September 10, 2014
Last verified: September 2014
  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:


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: December 2019
Estimated Primary Completion Date: December 2019 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813358

Contacts
Contact: Jennifer Gilmore 765-463-7537 jgilmore@medinst.com

  Hide Study Locations
Locations
United States, California
Kaiser Permanente Recruiting
San Francisco, California, United States, 94115
United States, Colorado
University of Denver Colorado Recruiting
Aurora, Colorado, United States, 80045
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33601
United States, Illinois
Heart Care Midwest Completed
Peoria, Illinois, United States, 61614
United States, Iowa
Iowa Heart Center Recruiting
West Des Moines, Iowa, United States, 50266
United States, Massachusetts
University of Massachusetts Recruiting
Worcester, Massachusetts, United States, 01655
United States, Michigan
University of Michigan Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
United States, New Hampshire
Dartmouth Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Susan Mathus    551-996-5722    smathus@hackensackUMC.org   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
New York Hospital of Queens Completed
Flushing, New York, United States, 11355
North Shore University Hospital Completed
Manhasset, New York, United States, 11030
New York University Completed
New York City, New York, United States, 10016
Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14642
United States, North Carolina
University of North Carolina Recruiting
Chapel Hill, North Carolina, United States, 27599
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
United States, Texas
DFW Vascular Group Recruiting
Dallas, Texas, United States, 75208
Baylor University Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75226
The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia Medical Center Recruiting
Charlottsville, Virginia, United States, 22908
United States, Washington
Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Canada, Ontario
London Health Sciences Centre Completed
London, Ontario, Canada, N6A 5W9
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: September 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
Endovascular Aneurysm Repair
Aortic Aneurysm
Thoracic

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

ClinicalTrials.gov processed this record on September 16, 2014