Ignite Creation Date:
2024-05-06 @ 10:09 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03180996
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-06-22
First Post:
2017-05-24
Brief Title:
Global Fenestrated Anaconda Clinical sTudy
Sponsor:
Vascutek Ltd
Organization:
Vascutek Ltd
Study Overview
Official Title:
A Prospective Global Multicentre Real World Outcome Study of Fenestrated Endovascular Aneurysm Repair Using the Fenestrated Anaconda Device
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-06
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:
Global FACT
Brief Summary:
This study is a prospective non-interventional multi-centre study of the Vascutek Fenestrated Anaconda system and is essentially a post-market study The Vascutek Fenestrated Anaconda system is a custom made device used for the treatment of Abdominal Aortic Aneurysm
Detailed Description:
Abdominal Aortic Aneurysm AAA is a life threatening disease Endovascular repair of infrarenal abdominal aortic aneurysms EVAR has replaced open surgical repair as the standard of care treatment for most patients Endovascular repair offers several benefits over open surgical repair including less invasive procedure faster recovery lower morbidity and lower early post-operative mortality The configuration of vascular anatomy is important to the successful placement and subsequent performance of infrarenal EVAR devices In particular aortic neck angulation and length are important for the success of EVAR Challenging necks with an aortic diameter 28 mm angulation 60 length 10mm circumferential thrombus reversed tapered configuration or neck with bulging make it more difficult to oppose the endograft to the aortic wall and are related to an increased risk of type Ia endoleak and reinterventions In order to overcome these issues fenestrated and branched stent grafts have been developed Fenestrated and branched endovascular aneurysm repair is now a routinely utilised procedure in the treatment of complex aortic aneurysm anatomy especially in patients unsuitable for open surgical repair
The Fenestrated Anaconda device Vascutek Ltd Glasgow Scotland UK has been commercially available since 2010 The Fenestrated Anaconda device has potential advantages over other FEVAR devices since it can be repositioned after deployment has a magnet-assisted limb cannulation and the device contains less metal allowing a better view of the radiological markers on the device during intra-operative imaging Additionally the potential to position fenestrations anywhere in the main body is unrestricted due to the absence of other stent structures
This prospective real world study of the Fenestrated Anaconda device will provide insight into both the short and long term clinical outcomes of the device An attempt will be made to identify predictors of success or failure and this study will help to identify patients that are likely to benefit from repair and improve results The effect of FEVAR on post-operative patient reported quality of life will be assessed In addition the study will provide insight into the potential decline in renal function after FEVAR a well-known concern after both EVAR and FEVAR
The Fenestrated Anaconda device Vascutek Ltd Glasgow Scotland UK has been commercially available since 2010 The Fenestrated Anaconda device has potential advantages over other FEVAR devices since it can be repositioned after deployment has a magnet-assisted limb cannulation and the device contains less metal allowing a better view of the radiological markers on the device during intra-operative imaging Additionally the potential to position fenestrations anywhere in the main body is unrestricted due to the absence of other stent structures
This prospective real world study of the Fenestrated Anaconda device will provide insight into both the short and long term clinical outcomes of the device An attempt will be made to identify predictors of success or failure and this study will help to identify patients that are likely to benefit from repair and improve results The effect of FEVAR on post-operative patient reported quality of life will be assessed In addition the study will provide insight into the potential decline in renal function after FEVAR a well-known concern after both EVAR and FEVAR
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None