Zenith® AAA Endovascular Graft Clinical Study - Tabular View

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Zenith® AAA Endovascular Graft Clinical Study

This study has been completed.

Study NCT00196092. Last updated on December 7, 2007. Information provided by Cook

This Tabular View shows the required WHO registration data elements as marked by ^†

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:

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

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00196092

Organization ID

99-514

Secondary IDs ^††

Study Sponsor ^†

Cook

Collaborators ^††

Investigators ^†

Principal Investigator:

Roy Greenberg, M.D.

The Cleveland Clinic

Information Provided By

Cook

Verification Date

December 2007

First Received Date ^†

September 13, 2005

Last Updated Date

December 7, 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.