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Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices (LEOPARD)

Primary Purpose

Abdominal Aortic Aneurysm

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AFX EVAR AAA Graft System
FDA Approved EVAR AAA Graft Systems
Sponsored by
Endologix
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eliza Coffee Medical Center
  • Huntsville Hospital
  • Banner Good Samaritan Hospital
  • Carondelet Heart and Vascular Institute
  • Central Arkansas Veteran's Healthcare System
  • Long Beach VA Hospital
  • Sacramento Vascular Sugeons
  • Kaiser - Santa Clara
  • Penrose St. Francis Health
  • Hartford Hospital
  • Yale University
  • Mayo Jacksonville
  • Mount Sinai Medical Center
  • Vascular Institute of Central Florida
  • Sarasota Vascular Specialists
  • USF/Tampa VA
  • Emory/Grady
  • Navicent Health Medical Center
  • Peachtree Vascular Specialists
  • Prairie Education & Research Cooperative
  • Cadence Physician Group
  • Parkview Research Center
  • Franciscan - St. Francis Hospital
  • University of Iowa Healthcare
  • The Iowa Clinic Cardiovascular Services
  • Surgical Care Associates
  • Cardiovascular Research Foundation of Louisiana
  • Baton Rouge Vascular Specialty Center
  • VA Maryland Health Care System
  • Peninsula Regional Medical Center
  • Massachusetts General Hospital
  • St. Joseph Mercy Ann Arbor
  • Hattiesburg Clinic
  • North MS Medical Center
  • University of Missouri
  • Kansas City Vascular
  • Saint Louis University
  • The Vascular Group
  • VA Western New York Healthcare System
  • Wake Forest
  • University Hospitals Cleveland Medical Center
  • Cleveland Clinic
  • Innovation Center, Kettering Health Network
  • Neo Vascular (Lake West)
  • Geisinger Medical Center
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University
  • North Central Heart
  • Cardiothoracic & Vascular Surgeons
  • University of Texas Health
  • University of Vermont Medical Center
  • Sentara Vascular Specialists
  • Peacehealth Southwest Medical Center
  • University of Wisconsin
  • Medical College of Wisconsin
  • Clement J. Zablocki VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AFX EVAR AAA Graft System

FDA Approved EVAR AAA Graft Systems

Arm Description

Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.

Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.

Outcomes

Primary Outcome Measures

Number of Patients With Absence of Aneurysm Related Complications (ARC)
ARC is a composite of the most relevant EVAR outcomes and includes: Peri-Operative Death (< 30 days) Rupture Conversion to OSR Endoleaks; post-operative Migration (≥ 10mm) Aneurysm Enlargement (≥ 5mm) Endograft Limb Occlusions Reinterventions for device- or aneurysm-related complications

Secondary Outcome Measures

The Number of MAEs
Major Adverse Events
The Number of Aneurysm Related Complications (ARC)
ARC is a composite outcome
The Number of Participants With Aneurysm Related Mortality
Death related to the aneurysm
Number of Endoleaks Classified by Type
All Endoloeaks
Loss of Neck Apposition as Measured by Length in mm
Loss of Neck Apposition as measured by length in mm
Number of AAA Related Secondary Procedures
Number of AAA related secondary procedures
Number of Device Integrity Events
Number of device integrity events from device fractures and technical observations related to the stent graft
Number of Adjunctive Procedures Necessitated During the Implant Procedure.
Number of adjunctive procedures done during the implant procedure

Full Information

First Posted
March 6, 2015
Last Updated
November 1, 2021
Sponsor
Endologix
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1. Study Identification

Unique Protocol Identification Number
NCT02407457
Brief Title
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Acronym
LEOPARD
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

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2015 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Endologix

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
455 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AFX EVAR AAA Graft System
Arm Type
Active Comparator
Arm Description
Subjects randomized to receive the Endologix AFX Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
Arm Title
FDA Approved EVAR AAA Graft Systems
Arm Type
Active Comparator
Arm Description
Subjects randomized to receive the comparator AAA Endovascular Graft System for implantation to repair Abdominal Aortic Aneurysm via femoral access.
Intervention Type
Device
Intervention Name(s)
AFX EVAR AAA Graft System
Intervention Description
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
Intervention Type
Device
Intervention Name(s)
FDA Approved EVAR AAA Graft Systems
Primary Outcome Measure Information:
Title
Number of Patients With Absence of Aneurysm Related Complications (ARC)
Description
ARC is a composite of the most relevant EVAR outcomes and includes: Peri-Operative Death (< 30 days) Rupture Conversion to OSR Endoleaks; post-operative Migration (≥ 10mm) Aneurysm Enlargement (≥ 5mm) Endograft Limb Occlusions Reinterventions for device- or aneurysm-related complications
Time Frame
1 year
Secondary Outcome Measure Information:
Title
The Number of MAEs
Description
Major Adverse Events
Time Frame
At 30 days, 12 months, and annually up to five years
Title
The Number of Aneurysm Related Complications (ARC)
Description
ARC is a composite outcome
Time Frame
Post 12 Months up to Five Years
Title
The Number of Participants With Aneurysm Related Mortality
Description
Death related to the aneurysm
Time Frame
Up to Five Years
Title
Number of Endoleaks Classified by Type
Description
All Endoloeaks
Time Frame
Up to Five Years
Title
Loss of Neck Apposition as Measured by Length in mm
Description
Loss of Neck Apposition as measured by length in mm
Time Frame
Up to Five Years
Title
Number of AAA Related Secondary Procedures
Description
Number of AAA related secondary procedures
Time Frame
Up to Five Years
Title
Number of Device Integrity Events
Description
Number of device integrity events from device fractures and technical observations related to the stent graft
Time Frame
Up to Five Years
Title
Number of Adjunctive Procedures Necessitated During the Implant Procedure.
Description
Number of adjunctive procedures done during the implant procedure
Time Frame
Up to Five Years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female at least 18 years old Subjects with minimum of 2 year life expectancy Subjects have signed the informed consent document for data release 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: Currently participating in another study where primary endpoint has not been reached yet Known allergy to any of the device components Pregnant (females of childbearing potential only) Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Kwolek, MD
Organizational Affiliation
Endologix
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eliza Coffee Medical Center
City
Florence
State/Province
Alabama
ZIP/Postal Code
35630
Country
United States
Facility Name
Huntsville Hospital
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Banner Good Samaritan Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Carondelet Heart and Vascular Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85745
Country
United States
Facility Name
Central Arkansas Veteran's Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Long Beach VA Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Sacramento Vascular Sugeons
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
Kaiser - Santa Clara
City
Santa Clara
State/Province
California
ZIP/Postal Code
95051
Country
United States
Facility Name
Penrose St. Francis Health
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Hartford Hospital
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
61110
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
48097
Country
United States
Facility Name
Mayo Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mount Sinai Medical Center
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33140
Country
United States
Facility Name
Vascular Institute of Central Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Sarasota Vascular Specialists
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
USF/Tampa VA
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory/Grady
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Navicent Health Medical Center
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Peachtree Vascular Specialists
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Prairie Education & Research Cooperative
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62701
Country
United States
Facility Name
Cadence Physician Group
City
Winfield
State/Province
Illinois
ZIP/Postal Code
60190
Country
United States
Facility Name
Parkview Research Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46845
Country
United States
Facility Name
Franciscan - St. Francis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa Healthcare
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246
Country
United States
Facility Name
The Iowa Clinic Cardiovascular Services
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Surgical Care Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Cardiovascular Research Foundation of Louisiana
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Baton Rouge Vascular Specialty Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
VA Maryland Health Care System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Peninsula Regional Medical Center
City
Salisbury
State/Province
Maryland
ZIP/Postal Code
21801
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
St. Joseph Mercy Ann Arbor
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Hattiesburg Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
North MS Medical Center
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Kansas City Vascular
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63124
Country
United States
Facility Name
The Vascular Group
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
VA Western New York Healthcare System
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Wake Forest
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Innovation Center, Kettering Health Network
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Neo Vascular (Lake West)
City
Willoughby
State/Province
Ohio
ZIP/Postal Code
44094
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
North Central Heart
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Cardiothoracic & Vascular Surgeons
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
University of Texas Health
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Sentara Vascular Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Peacehealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Clement J. Zablocki VA Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53295
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15483279
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.
Results Reference
background
PubMed Identifier
3220297
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.
Results Reference
background
PubMed Identifier
15351191
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.
Results Reference
background
PubMed Identifier
20096611
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.
Results Reference
background
PubMed Identifier
22640466
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.
Results Reference
background
PubMed Identifier
20484396
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.
Results Reference
background

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Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices

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