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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00094575
Other study ID # 498
Secondary ID
Status Completed
Phase Phase 4
First received October 20, 2004
Last updated February 8, 2016
Start date October 2002
Est. completion date April 2012

Study information

Verified date February 2016
Source VA Office of Research and Development
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 881
Est. completion date April 2012
Est. primary completion date October 2011
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Endovascular Repair
Endovascular Repair
Standard Open Repair
Standard Open Repair

Locations

Country Name City State
United States New Mexico VA Health Care System, Albuquerque Albuquerque New Mexico
United States VA Maryland Health Care System, Baltimore Baltimore Maryland
United States VA Medical Center, Birmingham Birmingham Alabama
United States VA Boston Healthcare System, Brockton Campus Brockton Massachusetts
United States VA Western New York Healthcare System at Buffalo Buffalo New York
United States Jesse Brown VAMC (WestSide Division) Chicago Illinois
United States VA Medical Center, Cincinnati Cincinnati Ohio
United States VA Medical Center, Cleveland Cleveland Ohio
United States VA North Texas Health Care System, Dallas Dallas Texas
United States Atlanta VA Medical and Rehab Center, Decatur Decatur Georgia
United States VA Eastern Colorado Health Care System, Denver Denver Colorado
United States John D. Dingell VA Medical Center, Detroit Detroit Michigan
United States VA Medical Center, Durham Durham North Carolina
United States VA New Jersey Health Care System, East Orange East Orange New Jersey
United States North Florida/South Georgia Veterans Health System Gainesville Florida
United States Edward Hines, Jr. VA Hospital Hines Illinois
United States Michael E. DeBakey VA Medical Center (152) Houston Texas
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 Medical Center, Loma Linda Loma Linda California
United States VA Medical Center, Long Beach Long Beach California
United States Wlliam S. Middleton Memorial Veterans Hospital, Madison Madison Wisconsin
United States VA Medical Center, Memphis Memphis Tennessee
United States Zablocki VA Medical Center, Milwaukee Milwaukee Wisconsin
United States Minneapolis VA Health Care System Minneapolis Minnesota
United States New York Harbor HCS New York New York
United States Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock No. Little Rock Arkansas
United States VA Medical Center, Omaha Omaha Nebraska
United States VA Palo Alto Health Care System Palo Alto California
United States VA Medical Center, Philadelphia Philadelphia Pennsylvania
United States VA Pittsburgh Health Care System Pittsburgh Pennsylvania
United States VA Medical Center, Portland Portland Oregon
United States VA Salt Lake City Health Care System, Salt Lake City Salt Lake City Utah
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 Puget Sound Health Care System, Seattle Seattle Washington
United States James A. Haley Veterans Hospital, Tampa Tampa Florida
United States Southern Arizona VA Health Care System, Tucson Tucson Arizona
United States VA Medical Center, DC Washington District of Columbia
United States VA Connecticut Health Care System (West Haven) West Haven Connecticut
United States VA Greater Los Angeles Healthcare System, West LA West Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (10)

Findeiss LK. Comparing endovascular and open repair of abdominal aortic aneurysm. JAMA. 2010 Feb 10;303(6):514; author reply 514. doi: 10.1001/jama.2010.88. — View Citation

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 Aneurys — View Citation

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 ane — View Citation

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 v — View Citation

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.2 — View Citation

Lederle FA. Abdominal aortic aneurysm: still no pill. Ann Intern Med. 2013 Dec 17;159(12):852-3. — View Citation

Lederle FA. The rise and fall of abdominal aortic aneurysm. Circulation. 2011 Sep 6;124(10):1097-9. doi: 10.1161/CIRCULATIONAHA.111.052365. — View Citation

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. — View Citation

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. — View Citation

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 O — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause Mortality 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 No
Secondary 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. Participants were followed for the duration of the study, up to 9 years No
Secondary 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.
Outcome was assessed at 6 months and then yearly, up to 9 years No
Secondary 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.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years No
Secondary 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.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years No
Secondary 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.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years No
Secondary 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.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years No
Secondary 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.
Outcome was assessed at 6 months and yearly thereafter, up to 9 years No
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