Ignite Creation Date:
2024-05-06 @ 2:09 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01980901
Status:
COMPLETED
Last Update Posted:
2021-06-04
First Post:
2013-11-04
Brief Title:
Post-Approval Study of the OvationOvation Prime Abdominal Stent Graft System
Sponsor:
TriVascular Inc
Organization:
Endologix
Study Overview
Official Title:
A Post-Market Approved PMA Post-Approval Study to Evaluate the Long-Term Safety and Effectiveness of the OvationOvation Prime Abdominal Stent Graft System
Status:
COMPLETED
Status Verified Date:
2021-06
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:
None
Brief Summary:
The Post-Approval Study PAS will evaluate the real world data on the OvationOvation Prime Abdominal Stent Graft System along with the long-term data collected from the IDE cohort to monitor the long-term safety and effectiveness of the device
Detailed Description:
The purpose of the study is to demonstrate the long term safety and effectiveness of the OvationOvation Prime Abdominal Stent Graft System for the endovascular treatment of infrarenal abdominal aortic aneurysms in a post-approval environment
The clinical objective of the study is to evaluate the long term safety and effectiveness of the OvationOvation Prime Abdominal Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality
Additionally this study will evaluate the physician training program for modifications based on IDE and post-approval experience
The clinical objective of the study is to evaluate the long term safety and effectiveness of the OvationOvation Prime Abdominal Stent Graft System assessed at 5 years through freedom from Aneurysm-Related Mortality
Additionally this study will evaluate the physician training program for modifications based on IDE and post-approval experience
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