Ignite Creation Date:
2024-05-06 @ 1:21 AM
Last Modification Date:
2024-10-26 @ 11:02 AM
Study NCT ID:
NCT01783184
Status:
COMPLETED
Last Update Posted:
2020-10-06
First Post:
2013-01-31
Brief Title:
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
Sponsor:
Vascutek Ltd
Organization:
Vascutek Ltd
Study Overview
Official Title:
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms
Status:
COMPLETED
Status Verified Date:
2020-10
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:
None
Brief Summary:
The Vascutek Anaconda Stent Graft System for repair of Abdominal Aortic Aneurysms AAA is the subject of this observational study 180 patients will be implanted with the Anaconda Stent Graft System and will be followed-up annually for 5 years post-implant The study will satisfy the requirements of the French National Authority for Health Haute Autorité de santé and the data collected will be used for reimbursement renewal
Detailed Description:
Infrarenal abdominal aortic aneurysms may be treated with the introduction of an abdominal aortic stent graft via the femoral route This technique is commonly used in high surgical risk patients but can also be suitable under certain conditions for normal risk patients
Abdominal aortic stent grafts inserted via the femoral artery are used to treat infrarenal abdominal aortic aneurysms removing the need for an invasive surgical procedure
The aim of this observational study is to evaluate the long-term 5 year benefits of the technique by documenting the overall mortality complications endoleak migration rate of surgical conversion progression and rupture of the aneurysm in a cohort of patients who are representative of the treated population under real conditions of use
Abdominal aortic stent grafts inserted via the femoral artery are used to treat infrarenal abdominal aortic aneurysms removing the need for an invasive surgical procedure
The aim of this observational study is to evaluate the long-term 5 year benefits of the technique by documenting the overall mortality complications endoleak migration rate of surgical conversion progression and rupture of the aneurysm in a cohort of patients who are representative of the treated population under real conditions of use
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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