Ignite Creation Date:
2024-05-05 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 9:44 AM
Study NCT ID:
NCT00610090
Status:
TERMINATED
Last Update Posted:
2015-08-25
First Post:
2008-01-24
Brief Title:
Safety Study for the Treatment of Abdominal Aortic Aneurysms
Sponsor:
Duke Vascular Inc
Organization:
Duke Vascular Inc
Study Overview
Official Title:
A Phase II Single-arm Prospective Study of the Safety of the UniFit Aorto-uni-iliac Endoluminal Stent Graft for the Repair of Abdominal Aortic Aneurysms
Status:
TERMINATED
Status Verified Date:
2015-05
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:
UNITE
Brief Summary:
The primary study objective at this time is to follow out to 5 years post implant the safety of already enrolled subjects who were treated with the UniFit Aorto-uni-iliac AUI Endoluminal Stent Graft the study device for the repair of abdominal aortic aneurysms AAAs
Detailed Description:
This is a phase II single-arm prospective study of the safety of the study device for the repair of AAAs
The investigator will identify eligible patients and explain the study and study device placement procedure to each patient andor any available family members Patients who provide written informed consent will be evaluated for study eligibility within the time period identified under Duration of Treatment Patients who are confirmed to be eligible based on screening assessment findings will be enrolled in the study
After hospital discharge patients will attend study center visits at 30 days 6 months and 1 2 3 4 and 5 years post-procedure for follow-up evaluations
The investigator will identify eligible patients and explain the study and study device placement procedure to each patient andor any available family members Patients who provide written informed consent will be evaluated for study eligibility within the time period identified under Duration of Treatment Patients who are confirmed to be eligible based on screening assessment findings will be enrolled in the study
After hospital discharge patients will attend study center visits at 30 days 6 months and 1 2 3 4 and 5 years post-procedure for follow-up evaluations
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