Ignite Creation Date:
2024-05-05 @ 10:24 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01092117
Status:
COMPLETED
Last Update Posted:
2021-12-21
First Post:
2010-03-17
Brief Title:
Clinical Study of the TriVascular Ovation Abdominal Stent Graft System
Sponsor:
TriVascular Inc
Organization:
Endologix
Study Overview
Official Title:
A Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the Ovation Abdominal Stent Graft System
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:
None
Brief Summary:
The primary objectives of this study are to determine whether the Ovation Abdominal Stent Graft System is a safe and effective method of treating abdominal aortic aneurysms AAAs in those patients considered to be suitable candidates for open surgical repair
Detailed Description:
This is a Phase II prospective consecutive enrolling non-randomized multi-center clinical evaluation of the safety and effectiveness of the Ovation Abdominal Stent Graft System when used in the treatment of patients with AAA Treatment Group as compared to a performance goal Control Group
150 study patients will be enrolled at up to 40 institutions An additional 100 study patients will be enrolled in the continued access phase
150 study patients will be enrolled at up to 40 institutions An additional 100 study patients will be enrolled in the continued access phase
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