Zenith TX2® Post-market Approval Study
TX2 2PAS
Zenith TX2® TAA Endovascular Graft Post-approval Study
2 other identifiers
interventional
115
2 countries
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2009
Longer than P75 for not_applicable
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 19, 2008
CompletedFirst Posted
Study publicly available on registry
December 23, 2008
CompletedStudy Start
First participant enrolled
July 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2020
CompletedResults Posted
Study results publicly available
May 5, 2021
CompletedJune 4, 2021
May 1, 2021
10.6 years
December 19, 2008
April 13, 2021
May 10, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
Thoracic aortic aneurysm-related mortality defined as death from any cause occurring within 30 days of the initial procedure or a secondary intervention; or any death determined by the independent clinical events committee to be causally related to the initial implant procedure, secondary intervention, or rupture of the treated aneurysm.
5 years
Study Arms (1)
Endovascular repair
EXPERIMENTALtreatment
Interventions
Endovascular treatment with the study device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Kaiser Permanente
San Francisco, California, 94115, United States
University of Denver Colorado
Aurora, Colorado, 80045, United States
University of Florida
Gainesville, Florida, 32610, United States
Tampa General Hospital
Tampa, Florida, 33601, United States
Heart Care Midwest
Peoria, Illinois, 61614, United States
Iowa Heart Center
West Des Moines, Iowa, 50266, United States
University of Massachusetts
Worcester, Massachusetts, 01655, United States
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Cooper University Hospital
Camden, New Jersey, 08103, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
New York Hospital of Queens
Flushing, New York, 11355, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
New York University
New York, New York, 10016, United States
Strong Memorial Hospital
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
DFW Vascular Group
Dallas, Texas, 75208, United States
Baylor University Medical Center at Dallas
Dallas, Texas, 75226, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alan Saunders, MS, RAC; Manager, Biostatistics
- Organization
- Cook Research Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2008
First Posted
December 23, 2008
Study Start
July 10, 2009
Primary Completion
February 14, 2020
Study Completion
March 23, 2020
Last Updated
June 4, 2021
Results First Posted
May 5, 2021
Record last verified: 2021-05