Ignite Creation Date:
2024-05-06 @ 9:17 AM
Last Modification Date:
2024-10-26 @ 12:12 PM
Study NCT ID:
NCT02949297
Status:
COMPLETED
Last Update Posted:
2021-12-22
First Post:
2016-10-21
Brief Title:
Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption IDE Study
Sponsor:
Endologix
Organization:
Endologix
Study Overview
Official Title:
Expanding Patient Applicability With Polymer Sealing Ovation Alto Stent Graft Investigational Device Exemption IDE Study
Status:
COMPLETED
Status Verified Date:
2021-11
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:
ELEVATE
Brief Summary:
A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm AAA
Detailed Description:
A prospective clinical evaluation of the effectiveness of the Ovation Alto Abdominal Stent Graft System when used in the treatment of subjects with abdominal aortic aneurysm AAA The primary objective is to evaluate treatment success at 12 months with the Ovation Alto Abdominal Stent Graft system The study will have up to 16 sites and up to 75 patients based on attrition rates The follow-up intervals will be at 1 6 and 12 months following initial implant procedure
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