Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices (LEOPARD)
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|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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|