Abdominal Aortic Aneurysm
Conditions
Brief summary
The purpose of this study is to evaluate the safety and effectiveness of the Cook Zenith Endovascular Graft for the treatment of abdominal aortic (AAA), aortoiliac, and iliac aneurysms.
Interventions
DEVICECompassionate Use
Endovascular repair for compassionate use patients.
DEVICEHigh Risk
High Risk Endovascular repair.
DEVICERoll-in
Proctored entry.
DEVICESurgical
Surgery
DEVICEStandard Risk
Standard Endovascular repair
DEVICETreatment for females
Endovascular repair in female patients
DEVICEStandard Risk Continued Access
Continued Access Endovascular repair for standard risk patients.
DEVICEHigh Risk Continued Access
Continued Access Endovascular Repair for High Risk Patients.
Sponsors
Cook Group Incorporated
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm. 2. Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm. 3. Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.
Exclusion criteria
1. Patients less than 18 years of age. 2. Patient with a life expectancy less than 2 years. 3. Patients who are pregnant. 4. Patients unwilling to comply with the follow-up schedule. 5. Patient inability or refusal to give informed consent.
Outcome results
None listed