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Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01783184
Study type Observational
Source Vascutek Ltd.
Contact
Status Completed
Phase
Start date June 2012
Completion date December 2019
View Details
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