Abdominal Aortic Aneurysms, Aortoiliac 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 to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aortoiliac, and iliac aneurysms.
Interventions
DEVICEZenith Low Profile AAA Endovascular Graft and ancillary components
Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms 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
* Subject has at least one of the following * Aortic or aortoiliac aneurysm * Iliac aneurysm * Aneurysm with a history of growth
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 * Pregnant of breastfeeding or planning on becoming pregnant with 60 months * Unwilling to comply with the follow-up schedule
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients Without Major Adverse Events Within 30 Days | 30 days | Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation |
| Number of Patients With Device Success | 12 months | Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Endovascular Graft The Zenith Low Profile AAA Endovascular Graft and ancillary components
Zenith Low Profile AAA Endovascular Graft and ancillary components: Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 13 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Endovascular Graft |
|---|---|
| Age, Continuous | 70.5 years STANDARD_DEVIATION 8.9 |
| Diabetes No | 47 Participants |
| Diabetes Yes | 15 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 61 Participants |
| Region of Enrollment United States | 62 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 58 Participants |
| Smoking Status Current | 16 Participants |
| Smoking Status Never | 6 Participants |
| Smoking Status Past | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 13 / 62 |
| other Total, other adverse events | 7 / 62 |
| serious Total, serious adverse events | 49 / 62 |
Outcome results
Primary
Number of Patients With Device Success
Device success will be measured with none of the following: type I or III endoleaks requiring re-intervention, graft limb occlusion, aneurysm rupture or conversion to open surgical repair, aneurysm enlargement greater than 0.5 cm
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Graft | Number of Patients With Device Success | 57 Participants |
Primary
Number of Patients Without Major Adverse Events Within 30 Days
Major adverse events include all-cause death, Q-wave MI, renal failure requiring dialysis, paralysis, stroke, bowel ischemia, re-intubation
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Endovascular Graft | Number of Patients Without Major Adverse Events Within 30 Days | 62 Participants |