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Sponsored by: |
Cook |
Information provided by: | Cook |
ClinicalTrials.gov Identifier: | NCT00196092 |
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.
Condition | Intervention |
Abdominal Aortic Aneurysm |
Device: Roll-in Device: Surgical Device: Standard Risk Device: High Risk Device: Compassionate Use Device: Treatment for females Device: Standard Risk Continued Access Device: High Risk Continued Access |
MedlinePlus related topics: | Aneurysms |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Zenith® AAA Endovascular Graft Clinical Study |
Enrollment: | 819 |
Study Start Date: | January 2000 |
Study Completion Date: | July 2006 |
Arms | Assigned Interventions |
1
Roll-in
|
Device: Roll-in
Proctored entry.
|
2
Surgical
|
Device: Surgical
Surgery
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3
Standard Risk
|
Device: Standard Risk
Standard Endovascular repair
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4
High Risk
|
Device: High Risk
High Risk Endovascular repair.
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5
Compassionate Use
|
Device: Compassionate Use
Endovascular repair for compassionate use patients.
|
6
Treatment for females.
|
Device: Treatment for females
Endovascular repair in female patients
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7
Standard Risk Continued Access
|
Device: Standard Risk Continued Access
Continued Access Endovascular repair for standard risk patients.
|
8
High Risk Continued Access
|
Device: High Risk Continued Access
Continued Access Endovascular Repair for High Risk Patients.
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 99-514 |
First Received: | September 13, 2005 |
Last Updated: | December 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00196092 |
Health Authority: | United States: Food and Drug Administration |
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