|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
|||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information Fields | |||||
| Brief Title † | Zenith® AAA Endovascular Graft Clinical Study | ||||
| Official Title † | Zenith® AAA Endovascular Graft Clinical Study | ||||
| 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. |
||||
| Detailed Description | |||||
| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | |||||
| Secondary Outcome Measure † | |||||
| Condition † | Abdominal Aortic Aneurysm | ||||
| Intervention † | 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 |
||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 819 | ||||
| Start Date † | January 2000 | ||||
| Completion Date | July 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | |||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00196092 | ||||
| Organization ID | 99-514 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Cook | ||||
| Collaborators †† | |||||
| Investigators † |
|
||||
| Information Provided By | Cook | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | December 7, 2007 | ||||