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Zenith® AAA Endovascular Graft Clinical Study

This study has been completed.
Sponsor:
Information provided by:
Cook
ClinicalTrials.gov Identifier:
NCT00196092
First received: September 13, 2005
Last updated: December 7, 2007
Last verified: December 2007
History of Changes
  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

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

Resource links provided by NLM:

U.S. FDA Resources

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:

  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
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

No publications provided

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

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

ClinicalTrials.gov processed this record on October 16, 2012