Descending Thoracic Aortic Aneurysm
Conditions
Keywords
Endovascular Aneurysm Repair, Aortic Aneurysm, Thoracic
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.
Interventions
DEVICEZenith TX2® TAA Endovascular Graft
Endovascular treatment with the study device
Sponsors
Cook Research Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality | 5 years | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Repair treatment
Zenith TX2® TAA Endovascular Graft: Endovascular treatment with the study device | 115 |
| Total | 115 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 32 |
| Overall Study | Lost to Follow-up | 12 |
| Overall Study | other endpoints | 5 |
| Overall Study | Withdrawal by Subject | 20 |
Baseline characteristics
| Characteristic | Endovascular Repair |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 90 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 72 years STANDARD_DEVIATION 10.6 |
| Race/Ethnicity, Customized Asian | 3 Participants |
| Race/Ethnicity, Customized Black or African Black or African American | 11 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants |
| Race/Ethnicity, Customized Native Hawaiian - other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized White | 93 Participants |
| Region of Enrollment United States | 115 participants |
| Sex: Female, Male Female | 54 Participants |
| Sex: Female, Male Male | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 32 / 115 |
| other Total, other adverse events | 14 / 115 |
| serious Total, serious adverse events | 83 / 115 |
Outcome results
Primary
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.
Time frame: 5 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Repair | Number of Participants With Freedom From Thoracic Aortic Aneurysm-related Mortality | 114 Participants |
95% CI: [97.4, 100]