Ignite Creation Date:
2024-05-06 @ 1:05 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01726257
Status:
COMPLETED
Last Update Posted:
2023-02-27
First Post:
2012-10-19
Brief Title:
Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System
Sponsor:
Endologix
Organization:
Endologix
Study Overview
Official Title:
Prospective Multicenter Single Arm Safety and Effectiveness Study of Endovascular Abdominal Aortic Aneurysm Repair Using the Nellix System A Pivotal and Continued Access Study
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
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:
EVAS IDE
Brief Summary:
The objective of this study is to assess the safety and effectiveness of the Endologix Nellix System for the endovascular repair of infrarenal abdominal aortic aneurysms AAA
Detailed Description:
This study will evaluate the safety and effectiveness of the Nellix System among a wide range of physicians and in consecutively enrolled subjects to assess outcomes generalizability Following appropriate government and ethics committeeIRB approval the Nellix EndoVascular Sealing System will be implanted into eligible patients who are adequately informed and have consented to join the study Enrolled patients will undergo a high resolution contrast-enhanced computed tomography angiography CT scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation Follow-up visits will occur at 30 days 6 months and annually to 5 years to assess aneurysm morphology the status of the implanted devices and relevant laboratory test results
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None