Zenith® AAA Endovascular Graft Clinical Study

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: High Risk; Device: Treatment for females; Device: Roll-in; Device: Surgical; Device: Standard Risk; Device: Compassionate Use; Device: Standard Risk Continued Access; Device: High Risk Continued Access

• Registration Number: NCT00196092
• Lead Sponsor: Cook Group Incorporated

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

Not available

Study Timeline

• Study Start: 2000-01
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Study Completion: 2006-07
• Status Verified: 2007-12
• Last Update Submitted: 2015-03-11
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 819

Inclusion Criteria

1. Patients with an aortic or aortoiliac aneurysm with diameter greater than or equal to 4 cm.
2. Patients with an iliac aneurysm with diameter greater than or equal to 3.5 cm.
3. 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

1. Patients less than 18 years of age.
2. Patient with a life expectancy less than 2 years.
3. Patients who are pregnant.
4. Patients unwilling to comply with the follow-up schedule.
5. Patient inability or refusal to give informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	High Risk	High Risk
6	Treatment for females	Treatment for females.
1	Roll-in	Roll-in
2	Surgical	Surgical
3	Standard Risk	Standard Risk
5	Compassionate Use	Compassionate Use
7	Standard Risk Continued Access	Standard Risk Continued Access
8	High Risk Continued Access	High Risk Continued Access