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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Abdominal Aortic Aneurysm

Intervention / Treatment
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* Device: AFX EVAR AAA Graft System
* Device: FDA Approved EVAR AAA Graft Systems


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |