Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
819 participants
INTERVENTIONAL
2000-01-31
2006-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Roll-in
Roll-in
Proctored entry.
2
Surgical
Surgical
Surgery
3
Standard Risk
Standard Risk
Standard Endovascular repair
4
High Risk
High Risk
High Risk Endovascular repair.
5
Compassionate Use
Compassionate Use
Endovascular repair for compassionate use patients.
6
Treatment for females.
Treatment for females
Endovascular repair in female patients
7
Standard Risk Continued Access
Standard Risk Continued Access
Continued Access Endovascular repair for standard risk patients.
8
High Risk Continued Access
High Risk Continued Access
Continued Access Endovascular Repair for High Risk Patients.
Interventions
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Roll-in
Proctored entry.
Surgical
Surgery
Standard Risk
Standard Endovascular repair
High Risk
High Risk Endovascular repair.
Compassionate Use
Endovascular repair for compassionate use patients.
Treatment for females
Endovascular repair in female patients
Standard Risk Continued Access
Continued Access Endovascular repair for standard risk patients.
High Risk Continued Access
Continued Access Endovascular Repair for High Risk Patients.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Cook Group Incorporated
INDUSTRY
Principal Investigators
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Roy Greenberg, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Other Identifiers
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99-514
Identifier Type: -
Identifier Source: org_study_id
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