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Aortic AneurysmPhase 4OVERNCT00094575

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

A Phase 4 study testing Endovascular Repair and Standard Open Repair in people with Aortic Aneurysm, run by VA Office of Research and Development at 42 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 cost and quality of life associated with these two strategies for AAA repair will be compared. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Aortic Aneurysm
What is being tested?
Endovascular Repair and Standard Open Repair
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
881 participants
Where
42 sitesUnited States
Study dates
Oct 2002to Apr 2012
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

42 sites in 1 country.

42 sites in 1 country

United States42 sites

  • New Mexico VA Health Care System, Albuquerque

    Albuquerque, New Mexico, 87108-5153

  • VA Maryland Health Care System, Baltimore

    Baltimore, Maryland, 21201

  • VA Medical Center, Birmingham

    Birmingham, Alabama, 35233

  • VA Boston Healthcare System, Brockton Campus

    Brockton, Massachusetts, 02301

  • VA Western New York Healthcare System at Buffalo

    Buffalo, New York, 14215

  • Jesse Brown VAMC (WestSide Division)

    Chicago, Illinois, 60612

  • VA Medical Center, Cincinnati

    Cincinnati, Ohio, 45220

  • VA Medical Center, Cleveland

    Cleveland, Ohio, 44106

  • VA North Texas Health Care System, Dallas

    Dallas, Texas, 75216

  • Atlanta VA Medical and Rehab Center, Decatur

    Decatur, Georgia, 30033

  • VA Eastern Colorado Health Care System, Denver

    Denver, Colorado, 80220

  • John D. Dingell VA Medical Center, Detroit

    Detroit, Michigan, 48201

  • VA Medical Center, Durham

    Durham, North Carolina, 27705

  • VA New Jersey Health Care System, East Orange

    East Orange, New Jersey, 07018

  • North Florida/South Georgia Veterans Health System

    Gainesville, Florida, 32608

  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141-5000

  • Michael E. DeBakey VA Medical Center (152)

    Houston, Texas, 77030

  • Richard Roudebush VA Medical Center, Indianapolis

    Indianapolis, Indiana, 46202-2884

  • VA Medical Center, Iowa City

    Iowa City, Iowa, 52246-2208

  • VA Medical Center, Lexington

    Lexington, Kentucky, 40502

  • VA Medical Center, Loma Linda

    Loma Linda, California, 92357

  • VA Medical Center, Long Beach

    Long Beach, California, 90822

  • Wlliam S. Middleton Memorial Veterans Hospital, Madison

    Madison, Wisconsin, 53705

  • VA Medical Center, Memphis

    Memphis, Tennessee, 38104

  • Zablocki VA Medical Center, Milwaukee

    Milwaukee, Wisconsin, 53295-1000

  • Minneapolis VA Health Care System

    Minneapolis, Minnesota, 55417

  • New York Harbor HCS

    New York, New York, 10010

  • Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock

    No. Little Rock, Arkansas, 72114-1706

  • VA Medical Center, Omaha

    Omaha, Nebraska, 68105-1873

  • VA Palo Alto Health Care System

    Palo Alto, California, 94304-1290

  • VA Medical Center, Philadelphia

    Philadelphia, Pennsylvania, 19104

  • VA Pittsburgh Health Care System

    Pittsburgh, Pennsylvania, 15240

  • VA Medical Center, Portland

    Portland, Oregon, 97201

  • VA Salt Lake City Health Care System, Salt Lake City

    Salt Lake City, Utah, 84148

  • VA San Diego Healthcare System, San Diego

    San Diego, California, 92161

  • VA Medical Center, San Francisco

    San Francisco, California, 94121

  • VA Puget Sound Health Care System, Seattle

    Seattle, Washington, 98108

  • James A. Haley Veterans Hospital, Tampa

    Tampa, Florida, 33612

  • Southern Arizona VA Health Care System, Tucson

    Tucson, Arizona, 85723

  • VA Medical Center, DC

    Washington D.C., District of Columbia, 20422

  • VA Connecticut Health Care System (West Haven)

    West Haven, Connecticut, 06516

  • VA Greater Los Angeles Healthcare System, West LA

    West Los Angeles, California, 90073

Other trials in United States

About this study

Official title: 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.

Read 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 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.

Conditions
Aortic Aneurysm
Being tested
Endovascular Repair, Standard Open Repair
Keywords
Abdominal, Aortic Aneurysm, cost of AAA repair, Endovascular Repair, Grafts, Long-term survival, secondary outcomes
Medical subject headings
Aortic Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular RepairProcedure or surgery

    Endovascular Repair

  • Standard Open RepairProcedure or surgery

    Standard Open Repair

Study groups in NCT00094575
Study groupRoleWhat they receive
Arm 1Active comparatorStandard Open Repair of Abdominal Aortic Aneurysm
Receives: Procedure: Standard Open Repair
Arm 2Active comparatorEndovascular Repair of Abdominal Aortic Aneurysm
Receives: Procedure: Endovascular Repair

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause Mortality

    Participants vital status was assessed from randomization to end of study follow-up [10/15/2011] or death [whichever occurred first].

    Measured: Participants were followed for the duration of the study, up to 9 years

Secondary outcomes (7)

  1. Secondary Therapeutic Procedures

    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.

    Measured: Participants were followed for the duration of the study, up to 9 years

  2. SF-36 Mental Component Score (MCS)

    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.

    Measured: Outcome was assessed at 6 months and then yearly, up to 9 years

  3. SF-36 Physical Component Score (PCS)

    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.

    Measured: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

  4. SF-36 Physical Component Deaths Included Score (PCTD)

    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.

    Measured: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

  5. European Quality of Life-5 Dimension (EQ-5D) Index Score

    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.

    Measured: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

  6. European Quality of Life-5 Dimension (EQ-5D) Visual Analog Scale

    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.

    Measured: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

  7. International Index of Erectile Function (IIEF-5)

    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.

    Measured: Outcome was assessed at 6 months and yearly thereafter, up to 9 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Oct 2004 (estimated)
  2. Study startOct 2002
  3. Primary completionOct 2011
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
881 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00094575
Sponsor's protocol ID
498
Acronym
OVER
Status last verified
Feb 2016
First submitted
20 Oct 2004
Last updated
7 Mar 2016
Data monitoring committee
Yes

Publications

  • Lederle FA. Vascular disease: is AAA screening worth the cost? Nat Rev Cardiol. 2009 Oct;6(10):616-8. doi: 10.1038/nrcardio.2009.161. No abstract available.

    PubMed 19773791

  • Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, Lin PH, Jean-Claude JM, Cikrit DF, Swanson KM, Peduzzi PN; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial. JAMA. 2009 Oct 14;302(14):1535-42. doi: 10.1001/jama.2009.1426.

    PubMed 19826022

  • Dalainas I. Comparing endovascular and open repair of abdominal aortic aneurysm. JAMA. 2010 Feb 10;303(6):513; author reply 514. doi: 10.1001/jama.2010.86. No abstract available.

    PubMed 20145222

  • Lederle FA. The rise and fall of abdominal aortic aneurysm. Circulation. 2011 Sep 6;124(10):1097-9. doi: 10.1161/CIRCULATIONAHA.111.052365. No abstract available.

    PubMed 21900095

  • Lederle FA. The strange relationship between diabetes and abdominal aortic aneurysm. Eur J Vasc Endovasc Surg. 2012 Mar;43(3):254-6. doi: 10.1016/j.ejvs.2011.12.026. Epub 2012 Jan 9.

    PubMed 22237512

  • Stroupe KT, Lederle FA, Matsumura JS, Kyriakides TC, Jonk YC, Ge L, Freischlag JA; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness of open versus endovascular repair of abdominal aortic aneurysm in the OVER trial. J Vasc Surg. 2012 Oct;56(4):901-9.e2. doi: 10.1016/j.jvs.2012.01.086. Epub 2012 May 27.

    PubMed 22640466

  • Lederle FA, Freischlag JA, Kyriakides TC, Matsumura JS, Padberg FT Jr, Kohler TR, Kougias P, Jean-Claude JM, Cikrit DF, Swanson KM; OVER Veterans Affairs Cooperative Study Group. Long-term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med. 2012 Nov 22;367(21):1988-97. doi: 10.1056/NEJMoa1207481.

    PubMed 23171095

  • Lederle FA, Stroupe KT; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Cost-effectiveness at two years in the VA Open Versus Endovascular Repair Trial. Eur J Vasc Endovasc Surg. 2012 Dec;44(6):543-8. doi: 10.1016/j.ejvs.2012.10.002. Epub 2012 Oct 30.

    PubMed 23116986

  • Lederle FA. Abdominal aortic aneurysm: still no pill. Ann Intern Med. 2013 Dec 17;159(12):852-3. doi: 10.7326/0003-4819-159-12-201312170-00012. No abstract available.

    PubMed 24490269

  • Lal BK, Zhou W, Li Z, Kyriakides T, Matsumura J, Lederle FA, Freischlag J; OVER Veterans Affairs Cooperative Study Group. Predictors and outcomes of endoleaks in the Veterans Affairs Open Versus Endovascular Repair (OVER) Trial of Abdominal Aortic Aneurysms. J Vasc Surg. 2015 Dec;62(6):1394-404. doi: 10.1016/j.jvs.2015.02.003.

    PubMed 26598115

  • Lederle FA, Kyriakides TC, Stroupe KT, Freischlag JA, Padberg FT Jr, Matsumura JS, Huo Z, Johnson GR; OVER Veterans Affairs Cooperative Study Group. Open versus Endovascular Repair of Abdominal Aortic Aneurysm. N Engl J Med. 2019 May 30;380(22):2126-2135. doi: 10.1056/NEJMoa1715955.

    PubMed 31141634

  • Powell JT, Sweeting MJ, Ulug P, Blankensteijn JD, Lederle FA, Becquemin JP, Greenhalgh RM; EVAR-1, DREAM, OVER and ACE Trialists. Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years. Br J Surg. 2017 Feb;104(3):166-178. doi: 10.1002/bjs.10430.

    PubMed 28160528

  • Lederle FA, Stroupe KT, Kyriakides TC, Ge L, Freischlag JA; Open vs Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Long-term Cost-effectiveness in the Veterans Affairs Open vs Endovascular Repair Study of Aortic Abdominal Aneurysm: A Randomized Clinical Trial. JAMA Surg. 2016 Dec 1;151(12):1139-1144. doi: 10.1001/jamasurg.2016.2783.

    PubMed 27627802

  • Myers SA, Applequist BC, Huisinga JM, Pipinos II, Johanning JM. Gait kinematics and kinetics are affected more by peripheral arterial disease than by age. J Rehabil Res Dev. 2016;53(2):229-38. doi: 10.1682/JRRD.2015.02.0027.

    PubMed 27149635

  • Matsumura JS, Stroupe KT, Lederle FA, Kyriakides TC, Ge L, Freischlag JA; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Costs of repair of abdominal aortic aneurysm with different devices in a multicenter randomized trial. J Vasc Surg. 2015 Jan;61(1):59-65. doi: 10.1016/j.jvs.2014.08.003. Epub 2014 Sep 16.

    PubMed 25238728

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Endovascular Repair and Standard Open Repair in people with Aortic Aneurysm, run by VA Office of Research and Development at 42 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Mortality (time frame: Participants were followed for the duration of the study, up to 9 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00094575, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.

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