ClinicalTrials.gov
ClinicalTrials.gov Menu

Zenith® AAA Endovascular Graft Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00196092
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : March 12, 2015
Sponsor:
Information provided by:
Cook Group Incorporated

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 819 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Zenith® AAA Endovascular Graft Clinical Study
Study Start Date : January 2000
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Arm Intervention/treatment
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.




Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00196092


Sponsors and Collaborators
Cook Group Incorporated
Investigators
Principal Investigator: Roy Greenberg, M.D. The Cleveland Clinic

ClinicalTrials.gov Identifier: NCT00196092     History of Changes
Other Study ID Numbers: 99-514
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: March 12, 2015
Last Verified: December 2007

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases