Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
| Status: | Enrolling by invitation |
|---|---|
| Conditions: | Cardiology, Cardiology, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2015 |
| End Date: | September 2022 |
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
The objective of this post-market study 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 study to include a broad range of
experience. Imaging data will be evaluated by an independent core lab.
with anatomical fixation against other approved Endovascular systems with proximal fixation.
Multiple U.S clinical centers will be involved in the study to include a broad range of
experience. Imaging data will be evaluated by an independent core lab.
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.
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.
Inclusion Criteria:
1. Male or female at least 18 years old
2. Subjects with minimum of 2 year life expectancy
3. Subjects have signed the informed consent document for data release
4. Subjects with AAA and eligible for endovascular Abdominal Aortic Aneurysm Repair
Exclusion Criteria:
1. Currently participating in another study where primary endpoint has not been reached
yet
2. Known allergy to any of the device components
3. Pregnant (females of childbearing potential only)
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