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

September 13, 2005
December 7, 2007
January 2000
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Complete list of historical versions of study NCT00196092 on ClinicalTrials.gov Archive Site
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Zenith® AAA Endovascular Graft Clinical Study
Zenith® AAA Endovascular Graft Clinical Study

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.

Not Provided
Interventional
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Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Abdominal Aortic Aneurysm
  • Device: Roll-in
    Proctored entry.
  • Device: Surgical
    Surgery
  • Device: Standard Risk
    Standard Endovascular repair
  • Device: High Risk
    High Risk Endovascular repair.
  • Device: Compassionate Use
    Endovascular repair for compassionate use patients.
  • Device: Treatment for females
    Endovascular repair in female patients
  • Device: Standard Risk Continued Access
    Continued Access Endovascular repair for standard risk patients.
  • Device: High Risk Continued Access
    Continued Access Endovascular Repair for High Risk Patients.
  • 1
    Roll-in
    Intervention: Device: Roll-in
  • 2
    Surgical
    Intervention: Device: Surgical
  • 3
    Standard Risk
    Intervention: Device: Standard Risk
  • 4
    High Risk
    Intervention: Device: High Risk
  • 5
    Compassionate Use
    Intervention: Device: Compassionate Use
  • 6
    Treatment for females.
    Intervention: Device: Treatment for females
  • 7
    Standard Risk Continued Access
    Intervention: Device: Standard Risk Continued Access
  • 8
    High Risk Continued Access
    Intervention: Device: High Risk Continued Access
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
819
July 2006
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00196092
99-514
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Not Provided
Cook
Not Provided
Principal Investigator: Roy Greenberg, M.D. The Cleveland Clinic
Cook
December 2007

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