Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00522535
Status:
COMPLETED
Last Update Posted:
2021-10-26
First Post:
2007-08-27
Brief Title:
Prospective Aneurysm Trial High Angle Aorfix Bifurcated Stent Graft
Sponsor:
Lombard Medical
Organization:
Lombard Medical
Study Overview
Official Title:
Prospective Aneurysm Trial High Angle Aorfix Bifurcated Stent Graft
Status:
COMPLETED
Status Verified Date:
2021-10
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:
PYTHAGORAS
Brief Summary:
Purpose of this study The purpose of the study is to evaluate the safety and effectiveness of the Lombard Medical endovascular Aorfix AAA bifurcated stent graft in the treatment of abdominal aortic aorto-iliac and common iliac aneurysms with anatomies including angled aorta angled aneurysmal body or both between 0 and 90
Study hypothesis The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak migration and fracture at 12 months
Efficacy The 12 month all cause mortality rate in the Aorfix group will be non-inferior to the 12 month all cause mortality rate in the Open Control group
Safety The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group
Study hypothesis The primary efficacy hypothesis is the proportion of grafts remaining free from endoleak migration and fracture at 12 months
Efficacy The 12 month all cause mortality rate in the Aorfix group will be non-inferior to the 12 month all cause mortality rate in the Open Control group
Safety The rates of early serious adverse events between 0 and 30 days post-operative in the Aorfix groups will be non-inferior to the early serious adverse event rates between 0 and 30 days post-operative in the Open Control group
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