Zenith® AAA Endovascular Graft Clinical Study

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Zenith® AAA Endovascular Graft Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00196092
• Other study ID #: 99-514
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 11, 2015
• Start date: January 2000
• Est. completion date: July 2006

Study information

• Verified date: December 2007
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 819
• Est. completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cook