CompletedNot Applicable

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

United States455 participantsStarted 2015-03

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: 1 year

Trial details

NCT IDNCT02407457

SponsorEndologix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2018-10

Results submitted2020-06-22

View on ClinicalTrials.gov More Abdominal Aortic Aneurysm trials