Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices (LEOPARD)
|Abdominal Aortic Aneurysm||Device: AFX EVAR AAA Graft System Device: FDA Approved EVAR AAA Graft Systems||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Absence of Aneurysm Related Complications (ARC) [ Time Frame: five years ]
- MAEs [ Time Frame: at 30 days, 12 months, and annually up to five years ]
|Study Start Date:||March 2015|
|Estimated Study Completion Date:||September 2022|
|Estimated Primary Completion Date:||September 2017 (Final data collection date for primary outcome measure)|
Active Comparator: 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.
Device: AFX EVAR AAA Graft System
Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
Active Comparator: 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.
|Device: FDA Approved EVAR AAA Graft Systems|
This study is a prospective, randomized, multi-center study, intended to evaluate the outcomes of contemporary EVAR (Endovascular Aneurysm Repair) in a real world population. The study 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02407457
|United States, Mississippi|
|North MS Medical Center|
|Tupelo, Mississippi, United States, 38801|
|Study Director:||Avyava Sharma||Endologix|