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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: AFX EVAR AAA Graft System; Device: FDA Approved EVAR AAA Graft Systems

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.

• Study Type: Interventional
• Enrollment (Actual): 455
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Florence, Alabama, United States, 35630
      • Eliza Coffee Medical Center
    • Huntsville, Alabama, United States, 35801
      • Huntsville Hospital
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Good Samaritan Hospital
    • Tucson, Arizona, United States, 85745
      • Carondelet Heart and Vascular Institute
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Central Arkansas Veteran's Healthcare System
  • California
    • Long Beach, California, United States, 90822
      • Long Beach VA Hospital
    • Sacramento, California, United States, 95816
      • Sacramento Vascular Sugeons
    • Santa Clara, California, United States, 95051
      • Kaiser - Santa Clara
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Penrose St. Francis Health
  • Connecticut
    • New Britain, Connecticut, United States, 61110
      • Hartford Hospital
    • New Haven, Connecticut, United States, 48097
      • Yale University
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Jacksonville
    • Miami Beach, Florida, United States, 33140
      • Mount Sinai Medical Center
    • Orlando, Florida, United States, 32803
      • Vascular Institute of Central Florida
    • Sarasota, Florida, United States, 34232
      • Sarasota Vascular Specialists
    • Tampa, Florida, United States, 33606
      • USF/Tampa VA
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory/Grady
    • Macon, Georgia, United States, 31201
      • Navicent Health Medical Center
    • Stockbridge, Georgia, United States, 30281
      • Peachtree Vascular Specialists
  • Illinois
    • Springfield, Illinois, United States, 62701
      • Prairie Education & Research Cooperative
    • Winfield, Illinois, United States, 60190
      • Cadence Physician Group
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Research Center
    • Indianapolis, Indiana, United States, 46237
      • Franciscan - St. Francis Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52246
      • University of Iowa Healthcare
    • West Des Moines, Iowa, United States, 50266
      • The Iowa Clinic Cardiovascular Services
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Surgical Care Associates
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Cardiovascular Research Foundation of Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • Baton Rouge Vascular Specialty Center
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • VA Maryland Health Care System
    • Salisbury, Maryland, United States, 21801
      • Peninsula Regional Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • St. Joseph Mercy Ann Arbor
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39402
      • Hattiesburg Clinic
    • Tupelo, Mississippi, United States, 38801
      • North MS Medical Center
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri
    • North Kansas City, Missouri, United States, 64116
      • Kansas City Vascular
    • Saint Louis, Missouri, United States, 63124
      • Saint Louis University
  • New York
    • Albany, New York, United States, 12208
      • The Vascular Group
    • Buffalo, New York, United States, 14215
      • VA Western New York Healthcare System
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center
    • Kettering, Ohio, United States, 45429
      • Innovation Center, Kettering Health Network
    • Willoughby, Ohio, United States, 44094
      • Neo Vascular (Lake West)
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57108
      • North Central Heart
  • Texas
    • Austin, Texas, United States, 78756
      • Cardiothoracic & Vascular Surgeons
    • Houston, Texas, United States, 77030
      • University of Texas Health
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • Sentara Vascular Specialists
  • Washington
    • Vancouver, Washington, United States, 98664
      • PeaceHealth Southwest Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • Clement J. Zablocki VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: AFX EVAR AAA Graft System; Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
Active Comparator: 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.	Device: FDA Approved EVAR AAA Graft Systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of MAEs	Major Adverse Events	At 30 days, 12 months, and annually up to five years
The Number of Aneurysm Related Complications (ARC)	ARC is a composite outcome	Post 12 Months up to Five Years
The Number of Participants With Aneurysm Related Mortality	Death related to the aneurysm	Up to Five Years
Number of Endoleaks Classified by Type	All Endoloeaks	Up to Five Years
Loss of Neck Apposition as Measured by Length in mm	Loss of Neck Apposition as measured by length in mm	Up to Five Years
Number of AAA Related Secondary Procedures	Number of AAA related secondary procedures	Up to Five Years
Number of Device Integrity Events	Number of device integrity events from device fractures and technical observations related to the stent graft	Up to Five Years
Number of Adjunctive Procedures Necessitated During the Implant Procedure.	Number of adjunctive procedures done during the implant procedure	Up to Five Years

Collaborators and Investigators

• Sponsor: Endologix
• Investigators: Principal Investigator: Christopher Kwolek, MD, Endologix

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): October 1, 2018
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: April 1, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): November 30, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: CP-0011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes