Zenith® AAA Endovascular Graft Clinical Study
Status
Completed
Conditions
Abdominal Aortic Aneurysm
Treatments
Device: High Risk
Device: Standard Risk Continued Access
Device: Compassionate Use
Device: Standard Risk
Device: Surgical
Device: Treatment for females
Device: Roll-in
Device: High Risk Continued Access
Details and patient eligibility
About
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.
Enrollment
819 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- 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 criteria
- 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.
Trial design
Primary purpose
Treatment
Allocation
Non-Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
819 participants in 8 patient groups
1
Other group
Description:
Roll-in
Treatment:
Device: Roll-in
2
Other group
Description:
Surgical
Treatment:
Device: Surgical
3
Other group
Description:
Standard Risk
Treatment:
Device: Standard Risk
4
Other group
Description:
High Risk
Treatment:
Device: High Risk
5
Other group
Description:
Compassionate Use
Treatment:
Device: Compassionate Use
6
Other group
Description:
Treatment for females.
Treatment:
Device: Treatment for females
7
Other group
Description:
Standard Risk Continued Access
Treatment:
Device: Standard Risk Continued Access
8
Other group
Description:
High Risk Continued Access
Treatment:
Device: High Risk Continued Access
Trial contacts and locations
0
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Data sourced from clinicaltrials.gov
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