NCT00196092

Zenith® AAA Endovascular Graft Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 819 (actual)
• Sponsor: Cook Group Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Roll-in	Proctored entry.
DEVICE	Surgical	Surgery
DEVICE	Standard Risk	Standard Endovascular repair
DEVICE	High Risk	High Risk Endovascular repair.
DEVICE	Compassionate Use	Endovascular repair for compassionate use patients.
DEVICE	Treatment for females	Endovascular repair in female patients
DEVICE	Standard Risk Continued Access	Continued Access Endovascular repair for standard risk patients.
DEVICE	High Risk Continued Access	Continued Access Endovascular Repair for High Risk Patients.

Timeline

• Start date: 2000-01-01
• Completion: 2006-07-01
• First posted: 2005-09-20
• Last updated: 2015-03-12