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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00094575
First received: October 20, 2004
Last updated: December 5, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Aortic Aneurysm
Procedure: Endovascular Repair
Procedure: Standard Open Repair
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: CSP #498 - Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • All-cause Mortality [ Time Frame: Patients will be followed at 6 and 12-month intervals throughout the 9-year study; the follow-up period will be 4-9 years. ] [ Designated as safety issue: No ]
    Participants vital status was assessed from randomization to end of study follow-up [10/15/2011] or death [whichever occurred first].


Enrollment: 881
Study Start Date: October 2002
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
Standard Open Repair of Abdominal Aortic Aneurysm
Procedure: Standard Open Repair
Active Comparator: Arm 2
Endovascular Repair of Abdominal Aortic Aneurysm
Procedure: Endovascular Repair

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 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 repair 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. Questions about the relative safety and effectiveness of FDA approved EVR devices 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 9 years with a proposed sample size of 900 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. The first DSMB meeting took place January 6, 2003. First annual meeting was held September 30, 2003; second DSMB meeting took place September 29, 2003. Third DSMB meeting held on April 19, 2004; second annual meeting was held on June 29, 2004. Fourth DSMB meeting was held on December 6, 2004; third annual meeting was held on March 15, 2005. The fifth DSMB meeting was held on July 19, 2005 and the fourth annual meeting was held March 21, 2006. The sixth DSMB meeting was held September 12, 2005. The seventh DSMB meeting was held on March 6, 2006. The eighth DSMB meeting was held on November 6, 2006. At its November 6, 2006 meeting, the DSMB discussed and approved unblinding of the study chair to prepare the short-term follow-up paper as specified in the study protocol. Initially the protocol called for this analysis to include one-year follow-up data. After discussions with the Trial Leadership, the DSMB approved use of two year follow-up data (reflected in DSMB minutes finalized February 20, 2007). This recommendation was subsequently approved by CSP in March 2007. The short-term outcomes manuscript was published in JAMA on October 14, 2009. The ninth DSMB meeting was held on May 14, 2007 and the fifth annual meeting was held on June 6, 2007. The tenth DSMB meeting was held on April 7, 2008. The eleventh DMC (name change only from DSMB to DMC) was held on June 22, 2009. The twelfth DMC meeting was held on May 24, 2010. A Site Investigator meeting was held in Boston, MA on June 9, 2010. The thirteenth DMC meeting was held on June 3, 2011 and a study close-out meeting was held on June 15, 2011 in Chicago, IL. The study's patient follow-up phase ended October 15, 2011.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00094575

  Hide Study Locations
Locations
United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, Arizona
Southern Arizona VA Health Care System, Tucson
Tucson, Arizona, United States, 85723
United States, Arkansas
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States, 72114-1706
United States, California
VA Medical Center, Loma Linda
Loma Linda, California, United States, 92357
VA Medical Center, Long Beach
Long Beach, California, United States, 90822
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
VA San Diego Healthcare System, San Diego
San Diego, California, United States, 92161
VA Medical Center, San Francisco
San Francisco, California, United States, 94121
VA Greater Los Angeles Healthcare System, West LA
West Los Angeles, California, United States, 90073
United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
United States, Connecticut
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States, 06516
United States, District of Columbia
VA Medical Center, DC
Washington, District of Columbia, United States, 20422
United States, Florida
North Florida/South Georgia Veterans Health System
Gainesville, Florida, United States, 32608
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, United States, 33612
United States, Georgia
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States, 30033
United States, Illinois
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, United States, 60612
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Iowa
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
United States, Kentucky
VA Medical Center, Lexington
Lexington, Kentucky, United States, 40502
United States, Maryland
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
United States, Massachusetts
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, United States, 02301
United States, Michigan
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States, 48201
United States, Minnesota
VA Medical Center
Minneapolis, Minnesota, United States, 55417
United States, Nebraska
VA Medical Center, Omaha
Omaha, Nebraska, United States, 68105-1873
United States, New Jersey
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, United States, 07018
United States, New Mexico
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, United States, 87108-5153
United States, New York
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States, 14215
New York Harbor HCS
New York, New York, United States, 10010
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
United States, Ohio
VA Medical Center, Cincinnati
Cincinnati, Ohio, United States, 45220
VA Medical Center, Cleveland
Cleveland, Ohio, United States, 44106
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
United States, Pennsylvania
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States, 19104
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States, 15240
United States, Tennessee
VA Medical Center, Memphis
Memphis, Tennessee, United States, 38104
United States, Texas
VA North Texas Health Care System, Dallas
Dallas, Texas, United States, 75216
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Utah
VA Salt Lake City Health Care System, Salt Lake City
Salt Lake City, Utah, United States, 84148
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
United States, Wisconsin
Wlliam S. Middleton Memorial Veterans Hospital, Madison
Madison, Wisconsin, United States, 53705
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, United States, 53295-1000
Sponsors and Collaborators
Investigators
Study Chair: Frank A. Lederle, MD Department of Veterans Affairs
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00094575     History of Changes
Other Study ID Numbers: 498
Study First Received: October 20, 2004
Results First Received: September 16, 2013
Last Updated: December 5, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Abdominal
Aortic Aneurysm
cost of AAA repair
Endovascular Repair
Grafts
Long-term survival
secondary outcomes

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on April 17, 2014