Ignite Creation Date:
2024-05-06 @ 3:53 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02407457
Status:
COMPLETED
Last Update Posted:
2021-11-30
First Post:
2015-03-06
Brief Title:
Post-Market Study to Assess Outcomes of Patients Treated With AFX System Compared to Other EVAR Devices
Sponsor:
Endologix
Organization:
Endologix
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEOPARD
Brief 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 US 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 11 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
Randomization will be 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None