Abdominal Aortic Aneurysm
Conditions
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.
Interventions
None listed
Sponsors
Vascutek Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall mortality rate | 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 | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years |
| Change in diameter of the aneurysm | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years |
| Rate of Type I, II and III endoleaks | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years |
| Surgical conversion rate | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years |
| Rate of endovascular or surgical revisions | Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years |
Countries
France
Outcome results
None listed