Status:
COMPLETED
Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)
Lead Sponsor:
VA Office of Research and Development
Conditions:
Aortic Aneurysm
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
A multi-center, randomized clinical trial that will compare endovascular repair with standard open surgery in the repair of abdominal aortic aneurysms (AAA). Long and short-term results as well as the...
Detailed Description
Primary Hypothesis: All-cause mortality will differ by 25% between Endovascular repair (EVR) and Open repair. Secondary Hypotheses: Procedure failure, short term (12-month) major morbidity, number of ...
Eligibility Criteria
Inclusion
- AAA with a maximum external diameter in any plane greater than or equal to 5 cm.
- An iliac aneurysm (associated with an AAA) with a maximum external diameter in any plane greater than or equal to 3 cm.
- AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal to 0.7 cm in diameter in 6 months.
- An AAA greater than or equal to 4.5 cm and the AAA has increased by greater than or equal to 1 cm in diameter in 12 months.
- An AAA greater than or equal to 4.5 cm and the AAA is saccular (i.e., a portion of the circumference of the aorta at the level of the aneurysm is considered normal based on CT scan or MRI).
- An AAA greater than or equal to 4.5 cm and the AAA is associated with distal embolism.
- as measured from two imaging studies (ultrasound CT scan or MRI) within the appropriate interval, the later one within 6 months of randomization.
Exclusion
- Patient has had a previous AAA repair procedure
- Evidence of AAA rupture by imaging test
- AAA is not elective (i.e., urgent or emergent operation, usually due to suspected rupture)
- Likelihood of poor compliance to the protocol
- Patient refused randomization
- Physician refused randomization
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
881 Patients enrolled
Trial Details
Trial ID
NCT00094575
Start Date
October 1 2002
End Date
April 1 2012
Last Update
March 7 2016
Active Locations (42)
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1
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
2
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
3
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
4
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357