Clinical trial NCT02407457: Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Official title: Multicenter, Post-Market Study to Assess Outcomes of Patients Treated With the AFX System Compared to Other EVAR Devices for Endovascular Abdominal Aortic Aneurysm Repair: LEOPARD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2015-04-03
Enrollment: 455
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this post-market trial is to evaluate Endologix AFX endovascular AAA system with anatomical fixation against other approved Endovascular systems with proximal fixation. Multiple U.S clinical centers will be involved in the trial to include a broad range of experience. Imaging data will be evaluated by an independent core lab.

Detailed description: This trial is a prospective, randomized, multi-center trial, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The trial is designed to compare the anatomically stabilized AFX Endograft System to a reference group of proximally fixated EVAR devices. Patients will be randomized between the two groups.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female at least 18 years old
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:

1. Currently participating in another study where primary endpoint has not been reached yet
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

Primary outcomes:
measure: Number of Patients With Absence of Aneurysm Related Complications (ARC)
timeFrame: 1 year
Secondary outcomes:
measure: The Number of MAEs
timeFrame: At 30 days, 12 months, and annually up to five years
measure: The Number of Participants With Aneurysm Related Complications (ARC)
timeFrame: Post 12 Months up to Five Years
measure: The Number of Participants With Aneurysm Related Mortality
timeFrame: Up to Five Years
measure: Number of Type Ia Endoleaks
timeFrame: Up to Five Years
measure: Number of Type Ib Endoleaks
timeFrame: Up to Five Years
measure: Number Endoleaks Type II
timeFrame: Up to Five Years
measure: Number of Endoleaks Type IIIa
timeFrame: Up to Five Years
measure: Number of Endoleaks Type IIIb
timeFrame: Up to Five Years
measure: Number of Participants With Aneurysm Rupture
timeFrame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
measure: Number of Participants With Open Conversion
timeFrame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
measure: Number of Participants With Aneurysm Expansion
timeFrame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
measure: Number of Patients With Endograft Occlusion
timeFrame: 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
measure: Number of Participants With Device-Related Secondary Interventions
timeFrame: 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
measure: Number of Patients With Adjunctive Procedures
timeFrame: Intraprocedural
Other outcomes:
Locations:
city: Florence
country: United States
facility: Eliza Coffee Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Huntsville Hospital
state: Alabama
city: Phoenix
country: United States
facility: Banner Good Samaritan Hospital
state: Arizona
city: Tucson
country: United States
facility: Carondelet Heart and Vascular Institute
state: Arizona
city: Little Rock
country: United States
facility: Central Arkansas Veteran's Healthcare System
state: Arkansas
city: Long Beach
country: United States
facility: Long Beach VA Hospital
state: California
city: Sacramento
country: United States
facility: Sacramento Vascular Sugeons
state: California
city: Santa Clara
country: United States
facility: Kaiser - Santa Clara
state: California
city: Colorado Springs
country: United States
facility: Penrose St. Francis Health
state: Colorado
city: New Britain
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Jacksonville
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Orlando
country: United States
facility: Vascular Institute of Central Florida
state: Florida
city: Sarasota
country: United States
facility: Sarasota Vascular Specialists
state: Florida
city: Tampa
country: United States
facility: USF/Tampa VA
state: Florida
city: Atlanta
country: United States
facility: Emory/Grady
state: Georgia
city: Macon
country: United States
facility: Navicent Health Medical Center
state: Georgia
city: Stockbridge
country: United States
facility: Peachtree Vascular Specialists
state: Georgia
city: Springfield
country: United States
facility: Prairie Education & Research Cooperative
state: Illinois
city: Winfield
country: United States
facility: Cadence Physician Group
state: Illinois
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Indianapolis
country: United States
facility: Franciscan - St. Francis Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Healthcare
state: Iowa
city: West Des Moines
country: United States
facility: The Iowa Clinic Cardiovascular Services
state: Iowa
city: Louisville
country: United States
facility: Surgical Care Associates
state: Kentucky
city: Baton Rouge
country: United States
facility: Cardiovascular Research Foundation of Louisiana
state: Louisiana
city: Baton Rouge
country: United States
facility: Baton Rouge Vascular Specialty Center
state: Louisiana
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
city: Salisbury
country: United States
facility: Peninsula Regional Medical Center
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Ann Arbor
state: Michigan
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Tupelo
country: United States
facility: North MS Medical Center
state: Mississippi
city: Columbia
country: United States
facility: University of Missouri
state: Missouri
city: North Kansas City
country: United States
facility: Kansas City Vascular
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Albany
country: United States
facility: The Vascular Group
state: New York
city: Buffalo
country: United States
facility: VA Western New York Healthcare System
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Kettering
country: United States
facility: Innovation Center, Kettering Health Network
state: Ohio
city: Willoughby
country: United States
facility: Neo Vascular (Lake West)
state: Ohio
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Sioux Falls
country: United States
facility: North Central Heart
state: South Dakota
city: Austin
country: United States
facility: Cardiothoracic & Vascular Surgeons
state: Texas
city: Houston
country: United States
facility: University of Texas Health
state: Texas
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Norfolk
country: United States
facility: Sentara Vascular Specialists
state: Virginia
city: Vancouver
country: United States
facility: Peacehealth Southwest Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Clement J. Zablocki VA Medical Center
state: Wisconsin
Study officials:
affiliation: Endologix
name: Christopher Kwolek, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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 OVER trial. J Vasc Surg. 2012 Oct;56(4):901-9.e2. doi: 10.1016/j.jvs.2012.01.086. Epub 2012 May 27.
citation: 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.