Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices (LEOPARD)
|ClinicalTrials.gov Identifier: NCT02407457|
Recruitment Status : Enrolling by invitation
First Posted : April 3, 2015
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Device: AFX EVAR AAA Graft System Device: FDA Approved EVAR AAA Graft Systems||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||800 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2015|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||September 2022|
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|
- Absence of Aneurysm Related Complications (ARC) [ Time Frame: five years ]
- MAEs [ Time Frame: at 30 days, 12 months, and annually up to five years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407457
|United States, Mississippi|
|North MS Medical Center|
|Tupelo, Mississippi, United States, 38801|
|Study Director:||Avyava Sharma||Endologix|