Ignite Creation Date:
2024-05-06 @ 1:10 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01744119
Status:
TERMINATED
Last Update Posted:
2016-05-24
First Post:
2012-11-29
Brief Title:
Vascutek Anaconda Abdominal Aortic Aneurysm AAA Post-Market Surveillance Registry
Sponsor:
Vascutek Ltd
Organization:
Vascutek Ltd
Study Overview
Official Title:
Vascutek Anaconda Stent Graft System for Infra-Renal Abdominal Aortic Aneurysm Repair
Status:
TERMINATED
Status Verified Date:
2016-05
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:
None
Brief Summary:
The purpose of this observational Post-Market Surveillance Registry is to gather post-market data on the performance of the CE marked Vascutek Anaconda Stent Graft System for the repair of Abdominal Aortic Aneurysms AAA The Study population consists of patients suitable for endovascular repair of AAA Patients will be followed at 1 3 6 12 18 24 36 48 and 60 months post-implantation
Detailed Description:
Vascutek Limited a world leader in the development of vascular grafts has combined their latest technological developments in polyester textile technology with unique endovascular design features to produce Anaconda the worlds next generation of AAA stent graft systems Intuitive and of a modular design Anaconda is the only repositionable device which also features exceptional flexibility The modular design comprises bifurcate bodies iliac legs and aortic cuffs Nitinol an alloy of nickel and titanium has self-expanding properties and forms the top ring-stent of the bifurcate body section The ring stent is composed of multiple turns of Nitinol wire that provides significantly increased hoop-strength enabling a conformable and secure haemostatic seal against the vessel wall to be achieved Nitinol hooks located adjacent to the ring stent anchor the graft in position thus preventing graft migration The iliac limbs are fully supported with Nitinol and the bifurcate bodies feature a distal contra-lateral lumen Nitinol support which in conjunction with a unique intrinsic magnet guidewire system facilitates cannulation of the bifurcate section
The system is available in a wide range of sizes thus making it a flexible and adaptable stent graft system with the potential to repair diverse patient anatomy
The system is available in a wide range of sizes thus making it a flexible and adaptable stent graft system with the potential to repair diverse patient anatomy
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