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

Completed · Not applicable

Conditions studied: Abdominal Aortic Aneurysm

In brief

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.

Key facts

Study ID

NCT02407457

Run by

Endologix

People needed

455

Starts

2015-03-01

Expected to finish

2022-10-01

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Yale University — New Haven, Connecticut, United States
• Mayo Jacksonville — Jacksonville, Florida, United States
• Mount Sinai Medical Center — Miami Beach, Florida, United States
• Vascular Institute of Central Florida — Orlando, Florida, United States
• Sarasota Vascular Specialists — Sarasota, Florida, United States
• USF/Tampa VA — Tampa, Florida, United States
• Emory/Grady — Atlanta, Georgia, United States
• Navicent Health Medical Center — Macon, Georgia, United States
• Peachtree Vascular Specialists — Stockbridge, Georgia, United States
• Prairie Education & Research Cooperative — Springfield, Illinois, United States
• Cadence Physician Group — Winfield, Illinois, United States
• Parkview Research Center — Fort Wayne, Indiana, United States
• Franciscan - St. Francis Hospital — Indianapolis, Indiana, United States
• University of Iowa Healthcare — Iowa City, Iowa, United States
• The Iowa Clinic Cardiovascular Services — West Des Moines, Iowa, United States
• Eliza Coffee Medical Center — Florence, Alabama, United States

Full record on ClinicalTrials.gov

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