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Zenith® AAA Endovascular Graft Clinical Study

This study has been completed.
Information provided by:
Cook Identifier:
First received: September 13, 2005
Last updated: March 11, 2015
Last verified: December 2007
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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Zenith® AAA Endovascular Graft Clinical Study

Resource links provided by NLM:

Further study details as provided by Cook:

Enrollment: 819
Study Start Date: January 2000
Study Completion Date: July 2006
Arms Assigned Interventions
Device: Roll-in
Proctored entry.
Device: Surgical
Standard Risk
Device: Standard Risk
Standard Endovascular repair
High Risk
Device: High Risk
High Risk Endovascular repair.
Compassionate Use
Device: Compassionate Use
Endovascular repair for compassionate use patients.
Treatment for females.
Device: Treatment for females
Endovascular repair in female patients
Standard Risk Continued Access
Device: Standard Risk Continued Access
Continued Access Endovascular repair for standard risk patients.
High Risk Continued Access
Device: High Risk Continued Access
Continued Access Endovascular Repair for High Risk Patients.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00196092

Sponsors and Collaborators
Principal Investigator: Roy Greenberg, M.D. The Cleveland Clinic
  More Information Identifier: NCT00196092     History of Changes
Other Study ID Numbers: 99-514
Study First Received: September 13, 2005
Last Updated: March 11, 2015

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on May 25, 2017