Status:
COMPLETED
Zenith® AAA Endovascular Graft Clinical Study
Lead Sponsor:
Cook Group Incorporated
Conditions:
Abdominal Aortic Aneurysm
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
- Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
- Patients with an aortic, aortoiliac, or iliac aneurysm with a history of growth greater than or equal to 0.5 cm per year.
Exclusion
- Patients less than 18 years of age.
- Patient with a life expectancy less than 2 years.
- Patients who are pregnant.
- Patients unwilling to comply with the follow-up schedule.
- Patient inability or refusal to give informed consent.
Key Trial Info
Start Date :
January 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2006
Estimated Enrollment :
819 Patients enrolled
Trial Details
Trial ID
NCT00196092
Start Date
January 1 2000
End Date
July 1 2006
Last Update
March 12 2015
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