Back to resultsZenith® AAA Endovascular Graft Clinical Study
Primary Purpose
Abdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Roll-in
Surgical
Standard Risk
High Risk
Compassionate Use
Treatment for females
Standard Risk Continued Access
High Risk Continued Access
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysm
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm Type
Other
Other
Other
Other
Other
Other
Other
Other
Arm Label
1
2
3
4
5
6
7
8
Arm Description
Roll-in
Surgical
Standard Risk
High Risk
Compassionate Use
Treatment for females.
Standard Risk Continued Access
High Risk Continued Access
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00196092
First Posted
September 13, 2005
Last Updated
March 11, 2015
Sponsor
Cook Group Incorporated
1. Study Identification
Unique Protocol Identification Number
NCT00196092
Brief Title
Zenith® AAA Endovascular Graft Clinical Study
Official Title
Zenith® AAA Endovascular Graft Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Cook Group Incorporated
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
819 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Roll-in
Arm Title
2
Arm Type
Other
Arm Description
Surgical
Arm Title
3
Arm Type
Other
Arm Description
Standard Risk
Arm Title
4
Arm Type
Other
Arm Description
High Risk
Arm Title
5
Arm Type
Other
Arm Description
Compassionate Use
Arm Title
6
Arm Type
Other
Arm Description
Treatment for females.
Arm Title
7
Arm Type
Other
Arm Description
Standard Risk Continued Access
Arm Title
8
Arm Type
Other
Arm Description
High Risk Continued Access
Intervention Type
Device
Intervention Name(s)
Roll-in
Intervention Description
Proctored entry.
Intervention Type
Device
Intervention Name(s)
Surgical
Intervention Description
Surgery
Intervention Type
Device
Intervention Name(s)
Standard Risk
Intervention Description
Standard Endovascular repair
Intervention Type
Device
Intervention Name(s)
High Risk
Intervention Description
High Risk Endovascular repair.
Intervention Type
Device
Intervention Name(s)
Compassionate Use
Intervention Description
Endovascular repair for compassionate use patients.
Intervention Type
Device
Intervention Name(s)
Treatment for females
Intervention Description
Endovascular repair in female patients
Intervention Type
Device
Intervention Name(s)
Standard Risk Continued Access
Intervention Description
Continued Access Endovascular repair for standard risk patients.
Intervention Type
Device
Intervention Name(s)
High Risk Continued Access
Intervention Description
Continued Access Endovascular Repair for High Risk Patients.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Greenberg, M.D.
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Zenith® AAA Endovascular Graft Clinical Study
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