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

NCT00094575 | Completed Phase 4 Results DMC

• 1 other identifier: 498
• Study Type: interventional
• Target: 881
• Locations: 1 country
• Sites: 42

Brief 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.

Conditions

Aortic Aneurysm

Keywords

Abdominal; Aortic Aneurysm; cost of AAA repair; Endovascular Repair; Grafts; Long-term survival; secondary outcomes

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

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

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

Secondary Outcomes (7)

• Secondary Therapeutic Procedures

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

• SF-36 Mental Component Score (MCS)

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

• SF-36 Physical Component Score (PCS)

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

• SF-36 Physical Component Deaths Included Score (PCTD)

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

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

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

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Standard Open Repair of Abdominal Aortic Aneurysm

Procedure: Standard Open Repair

Arm 2

ACTIVE COMPARATOR

Endovascular Repair of Abdominal Aortic Aneurysm

Procedure: Endovascular Repair

Interventions

Endovascular Repair PROCEDURE

Endovascular Repair

Arm 2

Standard Open Repair PROCEDURE

Standard Open Repair

Arm 1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (42)

VA Medical Center, Birmingham

Birmingham, Alabama, 35233, United States

Location

Southern Arizona VA Health Care System, Tucson

Tucson, Arizona, 85723, United States

Location

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

No. Little Rock, Arkansas, 72114-1706, United States

Location

VA Medical Center, Loma Linda

Loma Linda, California, 92357, United States

Location

VA Medical Center, Long Beach

Long Beach, California, 90822, United States

Location

VA Palo Alto Health Care System

Palo Alto, California, 94304-1290, United States

Location

VA San Diego Healthcare System, San Diego

San Diego, California, 92161, United States

Location

VA Medical Center, San Francisco

San Francisco, California, 94121, United States

Location

VA Greater Los Angeles Healthcare System, West LA

West Los Angeles, California, 90073, United States

Location

VA Eastern Colorado Health Care System, Denver

Denver, Colorado, 80220, United States

Location

VA Connecticut Health Care System (West Haven)

West Haven, Connecticut, 06516, United States

Location

VA Medical Center, DC

Washington D.C., District of Columbia, 20422, United States

Location

North Florida/South Georgia Veterans Health System

Gainesville, Florida, 32608, United States

Location

James A. Haley Veterans Hospital, Tampa

Tampa, Florida, 33612, United States

Location

Atlanta VA Medical and Rehab Center, Decatur

Decatur, Georgia, 30033, United States

Location

Jesse Brown VAMC (WestSide Division)

Chicago, Illinois, 60612, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141-5000, United States

Location

Richard Roudebush VA Medical Center, Indianapolis

Indianapolis, Indiana, 46202-2884, United States

Location

VA Medical Center, Iowa City

Iowa City, Iowa, 52246-2208, United States

Location

VA Medical Center, Lexington

Lexington, Kentucky, 40502, United States

Location

VA Maryland Health Care System, Baltimore

Baltimore, Maryland, 21201, United States

Location

VA Boston Healthcare System, Brockton Campus

Brockton, Massachusetts, 02301, United States

Location

John D. Dingell VA Medical Center, Detroit

Detroit, Michigan, 48201, United States

Location

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

VA Medical Center, Omaha

Omaha, Nebraska, 68105-1873, United States

Location

VA New Jersey Health Care System, East Orange

East Orange, New Jersey, 07018, United States

Location

New Mexico VA Health Care System, Albuquerque

Albuquerque, New Mexico, 87108-5153, United States

Location

VA Western New York Healthcare System at Buffalo

Buffalo, New York, 14215, United States

Location

New York Harbor HCS

New York, New York, 10010, United States

Location

VA Medical Center, Durham

Durham, North Carolina, 27705, United States

Location

VA Medical Center, Cincinnati

Cincinnati, Ohio, 45220, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

VA Medical Center, Portland

Portland, Oregon, 97201, United States

Location

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Health Care System

Pittsburgh, Pennsylvania, 15240, United States

Location

VA Medical Center, Memphis

Memphis, Tennessee, 38104, United States

Location

VA North Texas Health Care System, Dallas

Dallas, Texas, 75216, United States

Location

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

VA Salt Lake City Health Care System, Salt Lake City

Salt Lake City, Utah, 84148, United States

Location

VA Puget Sound Health Care System, Seattle

Seattle, Washington, 98108, United States

Location

Wlliam S. Middleton Memorial Veterans Hospital, Madison

Madison, Wisconsin, 53705, United States

Location

Zablocki VA Medical Center, Milwaukee

Milwaukee, Wisconsin, 53295-1000, United States

Location

Related Publications (15)

• 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.

  PMID: 19773791 RESULT

• 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.

  PMID: 19826022 RESULT

• 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.

  PMID: 20145222 RESULT

• 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.

  PMID: 21900095 RESULT

• 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.

  PMID: 22237512 RESULT

• 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.

  PMID: 22640466 RESULT

• 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.

  PMID: 23171095 RESULT

• 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.

  PMID: 23116986 RESULT

• 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.

  PMID: 24490269 RESULT

• 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.

  PMID: 26598115 RESULT

• 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.

  PMID: 31141634 DERIVED

• 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.

  PMID: 28160528 DERIVED

• 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.

  PMID: 27627802 DERIVED

• 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.

  PMID: 27149635 DERIVED

• 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.

  PMID: 25238728 DERIVED

MeSH Terms

Conditions

Aortic Aneurysm

Interventions

Endovascular Aneurysm Repair

Condition Hierarchy (Ancestors)

Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Blood Vessel Prosthesis Implantation; Vascular Grafting; Minimally Invasive Surgical Procedures; Prosthesis Implantation

Results Point of Contact

• Title: Dr. Frank A. Lederle
• Organization: VAMC Minneapolis, MN

Frank.Lederle@va.gov

612-725-2158

Study Officials

• Frank A. Lederle, MD

  Minneapolis Veterans Affairs Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2004
• First Posted: October 21, 2004
• Study Start: October 1, 2002
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2012
• Last Updated: March 7, 2016
• Results First Posted: December 31, 2013

Record last verified: 2016-02

Locations

US (42)