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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
455
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
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
Time frame: 1 year
The Number of MAEs
Major Adverse Events
Time frame: At 30 days, 12 months, and annually up to five years
The Number of Participants With Aneurysm Related Complications (ARC)
ARC is a composite outcome
Time frame: Post 12 Months up to Five Years
The Number of Participants With Aneurysm Related Mortality
Death related to the aneurysm
Time frame: Up to Five Years
Number of Type Ia Endoleaks
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.
Time frame: Up to Five Years
Number of Type Ib Endoleaks
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.
Time frame: Up to Five Years
Number Endoleaks Type II
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Eliza Coffee Medical Center
Florence, Alabama, United States
Huntsville Hospital
Huntsville, Alabama, United States
Banner Good Samaritan Hospital
Phoenix, Arizona, United States
Carondelet Heart and Vascular Institute
Tucson, Arizona, United States
Central Arkansas Veteran's Healthcare System
Little Rock, Arkansas, United States
Long Beach VA Hospital
Long Beach, California, United States
Sacramento Vascular Sugeons
Sacramento, California, United States
Kaiser - Santa Clara
Santa Clara, California, United States
Penrose St. Francis Health
Colorado Springs, Colorado, United States
Hartford Hospital
New Britain, Connecticut, United States
...and 46 more locations
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.
Time frame: Up to Five Years
Number of Endoleaks Type IIIa
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.
Time frame: Up to Five Years
Number of Endoleaks Type IIIb
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.
Time frame: Up to Five Years
Number of Participants With Aneurysm Rupture
Number of Participants with Aneurysm Rupture at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Participants With Open Conversion
Number of Participants that underwent an Open Conversions at 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Participants With Aneurysm Expansion
Number of Participants with Aneurysm Expansion at 12 Months, 24 Months, 36 Months, 48 months, 60 Months
Time frame: 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Patients With Endograft Occlusion
Number of Patients with Endograft Occlusion at 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Time frame: 12 Months, 24 Months, 36 Months, 48 Months and 60 Months
Number of Participants With Device-Related Secondary Interventions
Number of Participants with Device-Related Secondary Interventions at 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Time frame: 30 days, 12 Months, 24 Months, 36 Months, 48 Months, 60 Months
Number of Patients With Adjunctive Procedures
Number of patients with adjunctive procedure during the implant
Time frame: Intraprocedural