Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Abdominal Aortic Aneurysm
- Sponsor
- Vascutek Ltd.
- Enrollment
- 180
- Locations
- 24
- Primary Endpoint
- Change in diameter of the aneurysm
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA)
Exclusion Criteria
- •Patients for whom clinical follow-up is impossible and cannot return for check-up visits
Outcomes
Primary Outcomes
Change in diameter of the aneurysm
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Overall mortality rate
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Mortality rate related to rupture of the aneurysm and relationship to the stent
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Surgical conversion rate
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of endovascular or surgical revisions
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of Type I, II and III endoleaks
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years