Zenith® AAA Endovascular Graft Clinical Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

December 7, 2007

Start Date ^ICMJE

January 2000

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00196092 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Zenith® AAA Endovascular Graft Clinical Study

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Abdominal Aortic Aneurysm

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Other: Roll-in
Other: Surgical
Other: Standard Risk
Other: High Risk
Other: Compassionate Use
Other: Treatment for females.
Other: Standard Risk Continued Access
Other: High Risk Continued Access

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

819

Completion Date

July 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00196092

Responsible Party

Study ID Numbers ^ICMJE

99-514

Study Sponsor ^ICMJE

Cook

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Roy Greenberg, M.D.

The Cleveland Clinic

Information Provided By

Cook

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP