Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
NCT ID: NCT02407457
Last Updated: 2024-10-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
455 participants
INTERVENTIONAL
2015-03-31
2022-10-31
Brief Summary
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Detailed Description
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Randomization will be 1:1. Each investigator will select one comparator device of their choice before enrolling the first patient. The study will sequentially evaluate non-inferiority and superiority hypotheses.
Up to 80 sites with experience in EVAR and up to 800 subjects will participate in this study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AFX EVAR AAA Graft System
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
AFX EVAR AAA Graft System
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
FDA Approved EVAR AAA Graft Systems
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
FDA Approved EVAR AAA Graft Systems
Interventions
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AFX EVAR AAA Graft System
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
FDA Approved EVAR AAA Graft Systems
Eligibility Criteria
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Inclusion Criteria
2. Subjects with minimum of 2 year life expectancy
3. Subjects have signed the informed consent document for data release
4. Subjects with infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.
Exclusion Criteria
2. Known allergy to any of the device components
3. Pregnant (females of childbearing potential only)
4. Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
18 Years
ALL
No
Sponsors
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Endologix
INDUSTRY
Responsible Party
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Principal Investigators
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Christopher Kwolek, MD
Role: PRINCIPAL_INVESTIGATOR
Endologix
Locations
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Eliza Coffee Medical Center
Florence, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Banner Good Samaritan Hospital
Phoenix, Arizona, United States
Carondelet Heart and Vascular Institute
Tucson, Arizona, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
Long Beach VA Hospital
Long Beach, California, United States
Sacramento Vascular Sugeons
Sacramento, California, United States
Kaiser - Santa Clara
Santa Clara, California, United States
Penrose St. Francis Health
Colorado Springs, Colorado, United States
Hartford Hospital
New Britain, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Mayo Jacksonville
Jacksonville, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Vascular Institute of Central Florida
Orlando, Florida, United States
Sarasota Vascular Specialists
Sarasota, Florida, United States
USF/Tampa VA
Tampa, Florida, United States
Emory/Grady
Atlanta, Georgia, United States
Navicent Health Medical Center
Macon, Georgia, United States
Peachtree Vascular Specialists
Stockbridge, Georgia, United States
Prairie Education & Research Cooperative
Springfield, Illinois, United States
Cadence Physician Group
Winfield, Illinois, United States
Parkview Research Center
Fort Wayne, Indiana, United States
Franciscan - St. Francis Hospital
Indianapolis, Indiana, United States
University of Iowa Healthcare
Iowa City, Iowa, United States
The Iowa Clinic Cardiovascular Services
West Des Moines, Iowa, United States
Surgical Care Associates
Louisville, Kentucky, United States
Cardiovascular Research Foundation of Louisiana
Baton Rouge, Louisiana, United States
Baton Rouge Vascular Specialty Center
Baton Rouge, Louisiana, United States
VA Maryland Health Care System
Baltimore, Maryland, United States
Peninsula Regional Medical Center
Salisbury, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
North MS Medical Center
Tupelo, Mississippi, United States
University of Missouri
Columbia, Missouri, United States
Kansas City Vascular
North Kansas City, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
The Vascular Group
Albany, New York, United States
VA Western New York Healthcare System
Buffalo, New York, United States
Wake Forest
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Innovation Center, Kettering Health Network
Kettering, Ohio, United States
Neo Vascular (Lake West)
Willoughby, Ohio, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
North Central Heart
Sioux Falls, South Dakota, United States
Cardiothoracic & Vascular Surgeons
Austin, Texas, United States
University of Texas Health
Houston, Texas, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Sentara Vascular Specialists
Norfolk, Virginia, United States
Peacehealth Southwest Medical Center
Vancouver, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Clement J. Zablocki VA Medical Center
Milwaukee, Wisconsin, United States
Countries
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References
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Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2004 Oct 14;351(16):1607-18. doi: 10.1056/NEJMoa042002.
Volodos' NL, Karpovich IP, Shekhanin VE, Troian VI, Iakovenko LF. [A case of distant transfemoral endoprosthesis of the thoracic artery using a self-fixing synthetic prosthesis in traumatic aneurysm]. Grudn Khir. 1988 Nov-Dec;(6):84-6. No abstract available. Russian.
Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30-day operative mortality results: randomised controlled trial. Lancet. 2004 Sep 4-10;364(9437):843-8. doi: 10.1016/S0140-6736(04)16979-1.
Brown LC, Greenhalgh RM, Thompson SG, Powell JT; EVAR Trial Participants. Does EVAR alter the rate of cardiovascular events in patients with abdominal aortic aneurysm considered unfit for open repair? Results from the randomised EVAR trial 2. Eur J Vasc Endovasc Surg. 2010 Apr;39(4):396-402. doi: 10.1016/j.ejvs.2010.01.002. Epub 2010 Jan 21.
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.
De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9. doi: 10.1056/NEJMoa0909499.
Kwolek CJ, Ouriel K, Stucky FS, Rao VK, Pons PJ, Wilson SE, Kujath SW. Five-year results of the LEOPARD trial of commercially available endografts. J Vasc Surg. 2023 Aug;78(2):324-332.e2. doi: 10.1016/j.jvs.2023.04.011. Epub 2023 Apr 15.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP-0011
Identifier Type: -
Identifier Source: org_study_id
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