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

February 8, 2016 updated by: VA Office of Research and Development

CSP #498 - Open Versus Endovascular Repair (OVER) Trial for Abdominal Aortic Aneurysms

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

881

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
Standard Open Repair of Abdominal Aortic Aneurysm
Procedure: Standard Open Repair
Standard Open Repair
Active Comparator: Arm 2
Endovascular Repair of Abdominal Aortic Aneurysm
Procedure: Endovascular Repair
Endovascular Repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause Mortality
Time Frame: Participants were followed for the duration of the study, up to 9 years
Participants vital status was assessed from randomization to end of study follow-up [10/15/2011] or death [whichever occurred first].
Participants were followed for the duration of the study, up to 9 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Therapeutic Procedures
Time Frame: Participants were followed for the duration of the study, up to 9 years
This outcome includes any procedure that resulted directly or indirectly from the initial procedure and that required a separate trip to the procedure suite (with each trip to the procedure suite counting as one secondary procedure), including any unplanned surgical procedures within 30 days after the initial procedure and any additional aortoiliac procedures at any time.
Participants were followed for the duration of the study, up to 9 years
SF-36 Mental Component Score (MCS)
Time Frame: Outcome was assessed at 6 months and then yearly, up to 9 years

Change (over time) since baseline in Mental Component Score of SF-36. The MCS Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.

Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome was assessed at 6 months and then yearly, up to 9 years
SF-36 Physical Component Score (PCS)
Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

Change (over time) since baseline in Physical Component Score of SF-36. The PCS Score ranges from 0-100 with higher scores indicating better health Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.

Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years
SF-36 Physical Component Deaths Included Score (PCTD)
Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

Change (over time) since baseline in Physical Component Deaths included Score of SF-36.

The PCTD Score ranges from 0-100 with higher scores indicating better health. Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.

Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years
European Quality of Life-5 Dimension (EQ-5D) Index Score
Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

Change (over time) since baseline in EQ-5D. The EQ-5D Index Score ('thermometer scale') ranges from 0 (worst health status) to 100 (best health status). Since this outcome captures change since baseline, values could be below 0.

Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.

Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years
European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale
Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

Change (over time) since baseline in EQ-5D Visual Analog Scale. The EQ-5D Visual Analog Scale ranges from 0 (death) to 1 (perfect health). Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.

Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years
International Index of Erectile Function (IIEF-5)
Time Frame: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

Change (over time) since baseline in IIEF-5. The IIEF-5 Score ranges from 5-25 with higher scores indicating better erectile function.

Longitudinal mixed-effects model, adjusted for baseline values, was used to compare the two study arms. Treatment effect and change in quality-of-life measures over time were assessed in repeated measures models (with unstructured covariance) with the assigned repair method and baseline measurements used as covariates.

Least-squares mean changes from baseline were calculated at each time point; the reported overall least squares mean is calculated over all time points.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Study Chair: Frank A. Lederle, MD, Minneapolis Veterans Affairs Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

October 20, 2004

First Submitted That Met QC Criteria

October 20, 2004

First Posted (Estimate)

October 21, 2004

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 498

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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