Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00442065
Status:
COMPLETED
Last Update Posted:
2012-10-17
First Post:
2007-02-28
Brief Title:
ARBITER-II Aorfix Bifurcated Safety and Performance Trial Phase II Angulated Vessels
Sponsor:
Lombard Medical
Organization:
Lombard Medical
Study Overview
Official Title:
A Study to Assess the Acute Technical Success of Aorfix Stent Grafts in the Treatment of Abdominal Aortic and Aorto-Iliac Aneurysm Where a Significant Degree of Vessel Angulation Exists at the Neck of the Aneurysm
Status:
COMPLETED
Status Verified Date:
2012-10
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:
ARBITER-II
Brief Summary:
To assess the safety and performance of Aorfix Stent Grafts in the treatment of Abdominal Aortic and Aorto-Iliac Aneurysm where a significant degree of vessel angulation exists at the neck of the aneurysm or in the common iliac arteries
Detailed Description:
The Aorfix Stent Graft is currently a CE-marked product indicated for AAA where the angle of the aneurysm is 65o The objective of this study is to evaluate the safety and performance of the bifurcated Aorfix Stent Graft in the treatment of infrarenal abdominal aortic aneurysms and aorto-iliac aneurysms in infrarenal necks angulated 60o between 60 to 90 degrees as measured by 3-dimensional reconstruction in order to widen the indication
The investigation is a prospective open label single arm multi-centre clinical study The study group will consist of 25 evaluable participants In order to account for patients lost to follow up estimated at approximately 20 up to 30 patients will be enrolled in the study
The investigation is a prospective open label single arm multi-centre clinical study The study group will consist of 25 evaluable participants In order to account for patients lost to follow up estimated at approximately 20 up to 30 patients will be enrolled in the study
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