Ignite Creation Date:
2024-05-06 @ 9:07 AM
Last Modification Date:
2024-10-26 @ 12:10 PM
Study NCT ID:
NCT02907762
Status:
UNKNOWN
Last Update Posted:
2021-11-01
First Post:
2016-09-07
Brief Title:
Aorfix Intelliflex First in Human Study
Sponsor:
Lombard Medical
Organization:
Lombard Medical
Study Overview
Official Title:
Aorfix Generation IV Delivery System IntelliFlex Study
Status:
UNKNOWN
Status Verified Date:
2021-10
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:
FIH-NZ
Brief Summary:
The First In Human FIH study is a long-term single center non-randomized study established by Lombard Medical Inc to collect on-label data in the clinical setting on patients undergoing endovascular repair with IntelliFlex the latest generation of the Aorfix AAA Flexible Stent Graft Delivery System for treatment of abdominal aortic and aorto-iliac aneurysms in anatomy where the aorta in the aneurysm neck is bent through an angle between 0 and 90
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None