Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms, Iliac Aneurysms
Conditions
Keywords
Low Profile, Abdominal Aortic Aneurysms, Endovascular
Brief summary
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.
Interventions
DEVICEZenith(R) Low Profile AAA Endovascular Graft
The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
Sponsors
Cook Group 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
* Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size * Vessels suitable for endovascular access and aneurysm repair
Exclusion criteria
* Less than 18 years of age * Inability or refusal to give informed consent * Disease considerations that would compromise patient safety or study outcomes * Unsuitable arterial anatomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients With Major Adverse Events (MAE) | 30-day | MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation. |
| Patients With Device Failures | 12-month | Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm. |
Countries
China, Germany, Russia, Sweden, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Zenith® Low Profile AAA Endovascular Graft The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair. | 120 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Conversion | 2 |
| Overall Study | Death | 21 |
| Overall Study | In study follow-up | 71 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 13 |
Baseline characteristics
| Characteristic | Zenith® Low Profile AAA Endovascular Graft |
|---|---|
| Age, Continuous | 71.8 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 104 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 8 / 120 |
| serious Total, serious adverse events | 63 / 120 |
Outcome results
Primary
Patients With Device Failures
Device success at 12-month is defined as: Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.
Time frame: 12-month
Population: There were 5 patients died, and 2 patients withdrew.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zenith® Low Profile AAA Endovascular Graft | Patients With Device Failures | Converted to open surgical repair | 1 participants |
| Zenith® Low Profile AAA Endovascular Graft | Patients With Device Failures | Aneurysm expansion > 5 mm | 2 participants |
Comparison: Null hypothesis: The 12-month device success for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (84%).p-value: <0.0195% CI: [92.4, 99.4]Exact binomial test
Primary
Patients With Major Adverse Events (MAE)
MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.
Time frame: 30-day
Population: 1 patient experienced a re-intubation, which was adjudicated by the CEC as not related to AAA repair (related to a pre-existing condition).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zenith® Low Profile AAA Endovascular Graft | Patients With Major Adverse Events (MAE) | 1 participants |
Comparison: Null hypothesis: The 30-day Freedom from MAE for patients treated with the Zenith® Low Profile AAA Endovascular Graft does not meet the performance goal (88%).p-value: <0.0195% CI: [95.4, 100]Exact binomial test