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.

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

Abdominal Aortic Aneurysm

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.

AFX EVAR AAA Graft System

FDA Approved EVAR AAA Graft Systems

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

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

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.

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.

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.

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.

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.

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

Number of Participants that underwent an Open Conversions at 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

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

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

Number of patients with adjunctive procedure during the implant

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.

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

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

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

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

FDA Approved EVAR AAA Graft Systems

Total

Age, Continuous

Sex: Female, Male

Caucasian

Non-caucasian

Race/Ethnicity, Customized

ASA Class 1/2

ASA Class 3/4/5

The first row (ASA Class 1 / 2) reflects patients with fewer health concerns and the second row (Class 3/4/5), reflects patients with more severe medical co-morbidities. \*\*Note, this data reflects counts of participants, not frequency.

ASA Classification

Sharone Trifskin

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

Number of Patients With Absence of Aneurysm Related Complications (ARC)

Bleeding : 30 days

Bleeding : 12 Months

Bleeding : 24 Months

Bleeding : 36 Months

Bleeding : 48 Months

Bleeding : 60 Months

Cardiac : 30 days

Cardiac : 12 Months

Cardiac : 24 Months

Cardiac : 36 Months

Cardiac : 48 Months

Cardiac : 60 Months

GI : 30 days

GI : 12 Months

GI : 24 Months

GI : 36 Months

GI : 48 Months

GI : 60 Months

Malignancies : 30 days

Malignancies : 12 Months

Malignancies : 24 Months

Malignancies : 36 Months

Malignancies : 48 Months

Malignancies : 60 Months

Miscellaneous : 30 days

Miscellaneous : 12 Months

Miscellaneous : 24 Months

Miscellaneous : 36 Months

Miscellaneous : 48 Months

Miscellaneous : 60 Months

Neurological : 30 days

Neurological : 12 Months

Neurological : 24 Months

Neurological : 36 Months

Neurological : 48 Months

Neurological : 60 Months

Pulmonary : 30 days

Pulmonary : 12 Months

Pulmonary : 24 Months

Pulmonary : 36 Months

Pulmonary : 48 Months

Pulmonary : 60 Months

Renal : 30 days

Renal : 12 Months

Renal : 24 Months

Renal : 36 Months

Renal : 48 Months

Renal : 60 Months

Wound : 30 days

Wound : 12 Months

Wound : 24 Months

Wound : 36 Months

Wound : 48 Months

Wound : 60 Months

Vascular : 30 days

Vascular : 12 Months

Vascular : 24 Months

Vascular : 36 Months

Vascular : 48 Months

Vascular : 60 Months

The Number of MAEs

12 Months

24 Months

36 Months

48 Months

60 Months

The Number of Participants With Aneurysm Related Complications (ARC)

1 Year

2 Years

3 Years

4 Years

5 Years

The Number of Participants With Aneurysm Related Mortality

Number of Type Ia Endoleaks

Number of Type Ib Endoleaks

Number Endoleaks Type II

Number of Endoleaks Type IIIa

Number of Endoleaks Type IIIb

Number of Participants With Aneurysm Rupture

Number of Participants With Open Conversion

Number of Participants With Aneurysm Expansion

Number of Patients With Endograft Occlusion

30 Days

Number of Participants With Device-Related Secondary Interventions

Number of Patients With Adjunctive Procedures

Baseline

1 Month

6-Month

2-year

3-year

4-year

5-year

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

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Trial Timing

What is this trial about?

What are the participation requirements?