Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA)

Completed · Phase 4

Conditions studied: Aortic Aneurysm

In brief

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 cost and quality of life associated with these two strategies for AAA repair will be compared.

Key facts

Study ID

NCT00094575

Run by

VA Office of Research and Development

People needed

881

Starts

2002-10-01

Expected to finish

2012-04-01

Last updated by the study team

2016-03-07

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• VA Medical Center, Birmingham — Birmingham, Alabama, United States
• Southern Arizona VA Health Care System, Tucson — Tucson, Arizona, United States
• Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock — No. Little Rock, Arkansas, United States
• VA Medical Center, Loma Linda — Loma Linda, California, United States
• VA Medical Center, Long Beach — Long Beach, California, United States
• VA Palo Alto Health Care System — Palo Alto, California, United States
• VA San Diego Healthcare System, San Diego — San Diego, California, United States
• VA Medical Center, San Francisco — San Francisco, California, United States
• VA Greater Los Angeles Healthcare System, West LA — West Los Angeles, California, United States
• VA Eastern Colorado Health Care System, Denver — Denver, Colorado, United States
• VA Connecticut Health Care System (West Haven) — West Haven, Connecticut, United States
• VA Medical Center, DC — Washington D.C., District of Columbia, United States
• North Florida/South Georgia Veterans Health System — Gainesville, Florida, United States
• James A. Haley Veterans Hospital, Tampa — Tampa, Florida, United States
• Atlanta VA Medical and Rehab Center, Decatur — Decatur, Georgia, United States
• Jesse Brown VAMC (WestSide Division) — Chicago, Illinois, United States
• Edward Hines, Jr. VA Hospital — Hines, Illinois, United States
• Richard Roudebush VA Medical Center, Indianapolis — Indianapolis, Indiana, United States
• VA Medical Center, Iowa City — Iowa City, Iowa, United States
• VA Medical Center, Lexington — Lexington, Kentucky, United States
• VA Maryland Health Care System, Baltimore — Baltimore, Maryland, United States
• VA Boston Healthcare System, Brockton Campus — Brockton, Massachusetts, United States
• John D. Dingell VA Medical Center, Detroit — Detroit, Michigan, United States
• Minneapolis VA Health Care System — Minneapolis, Minnesota, United States
• VA Medical Center, Omaha — Omaha, Nebraska, United States

Full record on ClinicalTrials.gov

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