Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02407457
Recruitment Status : Active, not recruiting
First Posted : April 3, 2015
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Endologix

Brief Summary:
The objective of this post-market study 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 study to include a broad range of experience. Imaging data will be evaluated by an independent core lab.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Device: AFX EVAR AAA Graft System Device: FDA Approved EVAR AAA Graft Systems Not Applicable

Detailed Description:

This study is a prospective, randomized, multi-center study, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The study 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 2015
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. The number of participants with Absence of Aneurysm Related Complications (ARC) [ Time Frame: 1 year ]

    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 :
  1. The number of MAEs [ Time Frame: At 30 days, 12 months, and annually up to five years ]
    Major Adverse Events

  2. The number of Aneurysm Related Complications (ARC) [ Time Frame: Post 12 Months up to Five Years ]
    ARC is a composite outcome

  3. The Number of Participants with Aneurysm Related Mortality [ Time Frame: Up to Five Years ]
    Death related to the aneurysm

  4. Number of Endoleaks Classified by Type [ Time Frame: Up to Five Years ]
    All Endoloeaks

  5. Loss of Neck Apposition as measured by length in mm [ Time Frame: Up to Five Years ]
    Loss of Neck Apposition as measured by length in mm

  6. Number of AAA Related Secondary Procedures [ Time Frame: Up to Five Years ]
    Number of AAA related secondary procedures

  7. Number of Device integrity events [ Time Frame: Up to Five Years ]
    Number of device integrity events from device fractures and technical observations related to the stent graft

  8. Number of adjunctive procedures necessitated during the implant procedure. [ Time Frame: Up to Five Years ]
    Number of adjunctive procedures done during the implant procedure



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 AAA and eligible for endovascular Abdominal Aortic Aneurysm Repair

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407457


Locations
Layout table for location information
United States, Mississippi
North MS Medical Center
Tupelo, Mississippi, United States, 38801
Sponsors and Collaborators
Endologix
Investigators
Layout table for investigator information
Principal Investigator: Christopher Kwolek, MD Endologix
  Study Documents (Full-Text)

Documents provided by Endologix:
Study Protocol  [PDF] January 7, 2015


Publications of Results:

Layout table for additonal information
Responsible Party: Endologix
ClinicalTrials.gov Identifier: NCT02407457    
Other Study ID Numbers: CP-0011
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases