The purpose of this multi-center, randomized clinical trial is to compare endovascular repair systems 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.

Condition	Treatment or Intervention	Phase
Abdominal Aortic Aneurysm	Procedure: AAA Repair	Phase III

Further Study Details: 

Expected Total Enrollment:  1260

Primary Hypothesis: All-cause mortality will differ by 25% between Endovascular repair (EVR) and Open surgery.

Secondary Hypotheses:

Procedure failure, short term (12 month) major morbidity, number of hospital days, health-related quality of life and other procedure-related abnormalities will differ between the two AAA repair strategies.

Primary Outcomes:

All-cause mortality.

Interventions:

Patients will be randomized to one of these repair strategies for the elective treatment of AAA: (a) Open surgery or (b) Endovascular repair (using FDA-approved devices).

Study Abstract:

Aortic aneurysm is the tenth leading cause of death in older men; AAA accounts for the majority of these deaths (about 10,000 deaths per year in the United States). Since one in 22 veterans over the age of 50 have AAA and one in 200 have AAA with diameter greater or equal to 5.0 cm (making them candidates for elective repair), AAA is a major disease in the VA population. Recently, the FDA has approved two EVR systems for AAA; however, questions about their relative safety and effectiveness have been raised and remain unanswered. To answer these questions, this multi-center, randomized clinical trial comparing EVR with standard open surgery is proposed. Patients for whom elective repair of AAA is indicated and who are suitable candidates for both open repair and EVR will be eligible for the study. The anticipated duration of the study is 8 years with a proposed sample size of 1260 patients.

The first planning meeting took place on March 9-10, 2000 and the second planning meeting took place on November 6-7, 2000. The OVER protocol was submitted and reviewed by CSEC on May 10, 2001 and approved. The kickoff was June 12, 2002.

First annual meeting was held September 30, 2003; first DSMB meeting took place September 29, 2003. Second DSMB meeting was held on April 19, 2004. Second annual meeting was scheduled for June 29, 2004.

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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

Alabama
      Birmingham VAMC, Birmingham,  Alabama,  35294-0016,  United States; Recruiting
Arizona
      Southern Arizona VAHCS, Tucson,  Arizona,  85723,  United States; No longer recruiting
Arkansas
      Little Rock VAMC, Little Rock,  Arkansas,  72205,  United States; Recruiting
California
      Palo Alto VA Healthcare System, Palo Alto,  California,  94304,  United States; Recruiting
      SF VAMC, Vascular Surgery (112G), San Francisco,  California,  94121,  United States; Recruiting
      Long Beach VAMC (09/151-M2), Long Beach,  California,  90822,  United States; Recruiting
      Loma Linda VAMC, Loma Linda,  California,  92357,  United States; Recruiting
      WLA VAMC c/o Gonda Vascular Center, Los Angeles,  California,  90095-6908,  United States; Recruiting
      San Diego VAMC, San Diego,  California,  92161,  United States; Recruiting
Colorado
      Denver VA Medical Center (112), Denver,  Colorado,  80220,  United States; No longer recruiting
Connecticut
      VA CT Healthcare System, West Haven,  Connecticut,  06516,  United States; Recruiting
District of Columbia
      Washington VAMC (112), Washington,  District of Columbia,  20422,  United States; Recruiting
Florida
      James A. Haley Center VAMC, Tampa,  Florida,  33606,  United States; Recruiting
      Malcolm Randall VAMC, Gainesville,  Florida,  32610-0286,  United States; Recruiting
Illinois
      Chicago Healthcare System, Chicago,  Illinois,  60611,  United States; Recruiting
      VA Chicago Healthcare System - Westside, Chicago,  Illinois,  60612,  United States; Recruiting
      Hines VAMC, Hines,  Illinois,  60141,  United States; Recruiting
Indiana
      Indianapolis VAMC, Indianapolis,  Indiana,  46202,  United States; Recruiting
Iowa
      Iowa City VAMC, Iowa City,  Iowa,  52246-1009,  United States; No longer recruiting
      Univ of Iowa Hospital and Clinic, Iowa City,  Iowa,  52242-1009,  United States; No longer recruiting
Kentucky
      Lexington VAMC, Lexington,  Kentucky,  40511-1093,  United States; Recruiting
Maryland
      Baltimore VAMC, Baltimore,  Maryland,  21201-1595,  United States; Recruiting
Massachusetts
      Boston VA Healthcare System, West Roxbury,  Massachusetts,  02132,  United States; Recruiting
Michigan
      John D. Dingell VAMC, Detroit,  Michigan,  48201,  United States; Recruiting
Minnesota
      Minneapolis VAMC (112K), Minneapolis,  Minnesota,  55417,  United States; No longer recruiting
Nebraska
      Univ of Nebraska Medical Center, Omaha,  Nebraska,  68198-3280,  United States; Recruiting
New Jersey
      East Orange VAMC, East Orange,  New Jersey,  07019,  United States; Recruiting
New Mexico
      Albuquerque VAMC, Albuquerque,  New Mexico,  87108,  United States; Recruiting
New York
      NYU Medical Center, New York,  New York,  10016,  United States; Recruiting
      Western New York Healthcare System, Buffalo,  New York,  14215,  United States; Recruiting
North Carolina
      Durham VAMC, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      Cincinnati VAMC, Cincinnati,  Ohio,  45220-9848,  United States; Recruiting
      Louis Stoke Cleveland VAMC, Cleveland,  Ohio,  44106,  United States; Recruiting
Oregon
      Portland VAMC Oregon Health and Science Univ., Portland,  Oregon,  97239,  United States; No longer recruiting
Pennsylvania
      Pittsburgh VAMC, Pittsburgh,  Pennsylvania,  15240,  United States; Recruiting
      U Penn Hospital of Univ of Penn., Philadelphia,  Pennsylvania,  19104,  United States; No longer recruiting
Tennessee
      Memphis VAMC, Memphis,  Tennessee,  38104-2193,  United States; Recruiting
Texas
      Houston VAMC, Houston,  Texas,  77030,  United States; Recruiting
      Dallas VAMC (112L), Dallas,  Texas,  75216,  United States; Recruiting
Utah
      Salt Lake VAMC (112), Salt Lake City,  Utah,  84148,  United States; Recruiting
Washington
      Seattle VAMC (112), Seattle,  Washington,  98108,  United States; Recruiting
Wisconsin
      William S. Middleton VA, Madison,  Wisconsin,  53705,  United States; Recruiting
      Clement J. Zablocki VA Medical Center, Milwaukee,  Wisconsin,  53295,  United States; Recruiting

Study ID Numbers:  498
Record last reviewed:  October 2004
Last Updated:  October 21, 2004
Record first received:  October 20, 2004
ClinicalTrials.gov Identifier:  NCT00094575
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08