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

Abdominal Aortic Aneurysm Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02407457
Study type Interventional
Source Endologix
Contact
Status Active, not recruiting
Phase N/A
Start date March 2015
Completion date September 2022
View Details
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