NCT02407457

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 455 (actual)
• Sponsor: Endologix · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Abdominal Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	AFX EVAR AAA Graft System	Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
DEVICE	FDA Approved EVAR AAA Graft Systems

Timeline

• Start date: 2015-03-01
• Primary completion: 2018-10-01
• Completion: 2022-10-01
• First posted: 2015-04-03
• Last updated: 2024-10-01
• Results posted: 2020-09-21

Locations

56 sites across 1 country: United States

Regulatory

• FDA-regulated device study