Zenith® AAA Endovascular Graft Clinical Study - Full Text View

Purpose

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.

Condition	Intervention
Abdominal Aortic Aneurysm	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

MedlinePlus related topics:

Aneurysms

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Zenith® AAA Endovascular Graft Clinical Study

Further study details as provided by Cook:

Enrollment:	819
Study Start Date:	January 2000
Study Completion Date:	July 2006

Arms	Assigned Interventions
1 Roll-in	Device: Roll-in Proctored entry.
2 Surgical	Device: Surgical Surgery
3 Standard Risk	Device: Standard Risk Standard Endovascular repair
4 High Risk	Device: High Risk High Risk Endovascular repair.
5 Compassionate Use	Device: Compassionate Use Endovascular repair for compassionate use patients.
6 Treatment for females.	Device: Treatment for females Endovascular repair in female patients
7 Standard Risk Continued Access	Device: Standard Risk Continued Access Continued Access Endovascular repair for standard risk patients.
8 High Risk Continued Access	Device: High Risk Continued Access Continued Access Endovascular Repair for High Risk Patients.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196092

Sponsors and Collaborators

Cook

Investigators


Principal Investigator:	Roy Greenberg, M.D.	The Cleveland Clinic

More Information

Study ID Numbers:	99-514
First Received:	September 13, 2005
Last Updated:	December 7, 2007
ClinicalTrials.gov Identifier:	NCT00196092
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Aortic Diseases

Aneurysm

Aortic Aneurysm, Abdominal

Abdominal aortic aneurysm

Vascular Diseases

Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Cook
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00196092