Aortic Aneurysm, Penetrating Ulcer, Vascular Disease
Conditions
Keywords
Aortic Aneurysm, Aneurysm, Vascular Prosthesis, Vascular Disease, Blood Vessel Prosthesis Implantation
Brief summary
The Zenith® TX2® Low Profile TAA Endovascular Graft study is a clinical trial approved by US FDA to evaluate the safety and effectiveness of the Zenith® TX2® Low Profile TAA Endovascular Graft indicated for the treatment of patients with aneurysms/ulcers of the descending thoracic aorta having vessel structure suitable for repair.
Interventions
DEVICEZenith® TX2® Low Profile TAA Endovascular Graft
Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
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 aneurysm with diameter ≥ 5.0 cm * Descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year * Descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter
Exclusion criteria
* Less than 18 years of age * Life expectancy less than 2 years * Pregnant or breastfeeding or planning on becoming pregnant within 60 months * Unwilling to comply with the follow-up schedule * Inability or refusal to give informed consent * Less than 30 days beyond primary endpoint for other investigative drug or device study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Major Adverse Events (MAE) | 30 days | Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation \> 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room. |
| Patients With Device Failures | 12 months | Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm. |
Countries
Germany, Italy, Japan, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zenith® TX2® Low Profile TAA Endovascular Graft Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair | 110 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conversion to open repair | 1 |
| Overall Study | Death | 25 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Patients did not receive the device | 2 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | Zenith® TX2® Low Profile TAA Endovascular Graft |
|---|---|
| Age, Continuous | 72.2 years STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 25 / 110 |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 86 / 110 |
Outcome results
Primary
Patients With Device Failures
Device failure is defined as: Technical failure (inability to access or deploy the Zenith® TX2® Low Profile TAA Endovascular Graft or loss of patency at the time of deployment completion), or any of the following: type I or type III endoleaks requiring re-intervention, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zenith® TX2® Low Profile TAA Endovascular Graft | Patients With Device Failures | Did not receive the device (technical failures) | 2 participants |
| Zenith® TX2® Low Profile TAA Endovascular Graft | Patients With Device Failures | Aneurysm growth>5 mm | 2 participants |
| Zenith® TX2® Low Profile TAA Endovascular Graft | Patients With Device Failures | Aneurysm growth>5 mm and conversion to open repair | 1 participants |
| Zenith® TX2® Low Profile TAA Endovascular Graft | Patients With Device Failures | Endoleak requiring secondary intervention | 3 participants |
Comparison: Null Hypothesis: The 12-month device success for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.7%.p-value: <0.00195% CI: [86.2, 96.8]Exact binomial test
Primary
Patients With Major Adverse Events (MAE)
Major adverse event is defined as: All-cause death; Q-wave MI; cardiac event involving arrest, resuscitation, or balloon pump; ventilation \> 72 hours or re-intubation; pulmonary event requiring tracheostomy or chest tube; renal failure requiring permanent dialysis, hemofiltration, or kidney transplant in a patient with a normal pre-procedure serum creatinine level; bowel resection; stroke; paralysis; amputation involving more than toes; aneurysm or vessel leak requiring re-operation; deep vein thrombosis requiring surgical or lytic therapy; pulmonary embolism involving hemodynamic instability or surgery; coagulopathy requiring surgery; or wound complication requiring return to the operating room.
Time frame: 30 days
Population: 1 patient had a stroke and required ventilation \>72 hours/reintubation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zenith® TX2® Low Profile TAA Endovascular Graft | Patients With Major Adverse Events (MAE) | Stroke | 2 participants |
| Zenith® TX2® Low Profile TAA Endovascular Graft | Patients With Major Adverse Events (MAE) | Ventilation >72 hours/reintubation | 3 participants |
Comparison: Null hypothesis: The 30-day freedom from MAE for patients treated with the Zenith® TX2® Low Profile TAA Endovascular Graft does not meet the performance goal of 80.6%.p-value: <0.00195% CI: [91, 99]Exact binomial test