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Completed

NCT Number: NCT02407457

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

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.

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eliza Coffee Medical Center, Florence, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AFX EVAR AAA Graft System

Device

Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.

FDA Approved EVAR AAA Graft Systems

Device

Primary outcomes

  1. Number of Patients 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 outcomes

  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 Participants With 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 Type Ia Endoleaks

    Time frame: Up to Five Years

    Number of participants with Type Ia endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ia endoleak defined as persistent leak around the top of the stent graft identified during imaging surveillance at the different timepoints.

  5. Number of Type Ib Endoleaks

    Time frame: Up to Five Years

    Number of participants with Type Ib endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type Ib endoleak defined as persistent leak around the bottom of the stent graft identified during imaging surveillance at the different timepoints.

  6. Number Endoleaks Type II

    Time frame: Up to Five Years

    Number of participants with Type II endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type II endoleak defined as persistent blood flow into the aneurysm sac from branches of the aorta identified during imaging surveillance at the different timepoints.

  7. Number of Endoleaks Type IIIa

    Time frame: Up to Five Years

    Number of participants with Type IIIa endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIa endoleak defined as persistent leak from the overlapping parts of the stent graft identified during imaging surveillance at the different timepoints.

  8. Number of Endoleaks Type IIIb

    Time frame: Up to Five Years

    Number of participants with Type IIIb endoleaks at 12 months, 24 months, 36 months, 48 months and 60 months. Type IIIb endoleak defined as persistent leak as a consequence of graft rupture, identified during imaging surveillance at the different timepoints.

  9. Number of Participants With Aneurysm Rupture

    Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months

    Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months

  10. Number of Participants With Open Conversion

    Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months

    Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months

  11. Number of Participants With Aneurysm Expansion

    Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months

    Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months

  12. Number of Patients With Endograft Occlusion

    Time frame: 12 Months, 24 Months, 36 Months, 48 Months and 60 Months

    Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months

  13. Number of Participants With Device-Related Secondary Interventions

    Time frame: 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months

    Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months

  14. Number of Patients With Adjunctive Procedures

    Time frame: Intraprocedural

    Number of patients with adjunctive procedure during the implant

Sponsors and collaborators

Lead sponsor

Endologix

Industry

Registry information

Official study 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

Acronym: LEOPARD

Important dates

Study start
2015
Primary completion
2018
Study completion
2022
First posted
Apr 3, 2015
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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