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.
Brief Title
Zenith TX2® Post-market Approval Study
Completion Date
Completion Date Type
Actual
Conditions
Descending Thoracic Aortic Aneurysm
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Endovascular Aneurysm Repair
Aortic Aneurysm
Thoracic
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT00813358
Org Class
Industry
Org Full Name
Cook Group Incorporated
Org Study Id
08-005
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Zenith TX2® TAA Endovascular Graft Post-approval Study
Primary Outcomes
Outcome Description
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.
Outcome Measure
Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality
Outcome Time Frame
5 years
Secondary Ids
Secondary Id
370024, 2PAS
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Evan Lipsitz
Investigator Email
elipsitz@montefiore.org
Investigator Phone