Ignite Creation Date:
2024-05-05 @ 11:25 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01328197
Status:
COMPLETED
Last Update Posted:
2017-12-20
First Post:
2011-03-31
Brief Title:
Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Sponsor:
Bolton Medical
Organization:
Bolton Medical
Study Overview
Official Title:
A Phase I Clinical Study of the Safety and Performance of the Treovance Stent-Graft With Navitel Delivery System for Patients With Infrarenal Abdominal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2017-12
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 goal of the study is to assess the safety and performance of the Treovance device in subjects with infrarenal aortic aneurysms specifically to evaluate if the diseased pathology can be treated with an acceptable adverse event rate and that the device performs as expected The results of this study will permit the establishment of endpoints and clinical design for a subsequent US trial
Detailed Description:
None
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