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

Not Applicable

Completed

• Conditions: Abdominal Aortic Aneurysm
• Interventions: Device: AFX EVAR AAA Graft System; Device: FDA Approved EVAR AAA Graft Systems

• Registration Number: NCT02407457
• Lead Sponsor: Endologix

Brief Summary

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

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-06
• Study First Submitted QC: 2015-04-01
• Study First Posted: 2015-04-03
• Primary Completion: 2018-10
• Results First Submitted: 2020-06-22
• Results First Submitted QC: 2020-09-01
• Results First Posted: 2020-09-21
• Study Completion: 2022-10
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-04
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 455

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 infrarenal AAA who are assessed by the Investigator to be eligible for endovascular Abdominal Aortic Aneurysm Repair with the trial devices.

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)
4. Subjects with pre-existing EVAR, e.e. in need of repair/intervention of a previously failed EVAR

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AFX EVAR AAA Graft System	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.
FDA Approved EVAR AAA Graft Systems	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.

Primary Outcome Measures

Name	Time	Method
Number of Patients With Absence of Aneurysm Related Complications (ARC)	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

Name	Time	Method
The Number of MAEs	At 30 days, 12 months, and annually up to five years	Major Adverse Events
The Number of Participants With Aneurysm Related Complications (ARC)	Post 12 Months up to Five Years	ARC is a composite outcome
The Number of Participants With Aneurysm Related Mortality	Up to Five Years	Death related to the aneurysm
Number of Participants With Open Conversion	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
Number of Participants With Aneurysm Expansion	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 Type Ia Endoleaks	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.
Number of Type Ib Endoleaks	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.
Number Endoleaks Type II	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.
Number of Endoleaks Type IIIa	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.
Number of Endoleaks Type IIIb	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.
Number of Participants With Aneurysm Rupture	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
Number of Patients With Endograft Occlusion	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
Number of Participants With Device-Related Secondary Interventions	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
Number of Patients With Adjunctive Procedures	Intraprocedural	Number of patients with adjunctive procedure during the implant

Trial Locations

Locations (56)

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

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