Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
- Conditions
- Abdominal Aortic Aneurysm
- Registration Number
- NCT01783184
- Lead Sponsor
- Vascutek Ltd.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 180
- Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA)
- Patients for whom clinical follow-up is impossible and cannot return for check-up visits
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in diameter of the aneurysm Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years 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 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 Rate of Type I, II and III endoleaks Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
C.H. Prive Saint Martin
🇫🇷Caen, France
Hopital Prive de l'Estuaire
🇫🇷Le Havre, France
Centre Hospitalier Universitaire - Hopital Civil
🇫🇷Strasbourg, France
Clinique Vauban
🇫🇷Valenciennes, France
Clinique Aguilera
🇫🇷Biarritz, France
Clinique Casamance
🇫🇷Aubagne, France
Centre Hospitalier Jacques Coeur
🇫🇷Bourges, France
Clinique Saint Etienne
🇫🇷Bayonne, France
Infirmerie Protestante
🇫🇷Caluire Et Cuire, France
Centre Hospitalier Universitaire - Hopital Michallon
🇫🇷Grenoble, France
Clinique Villette
🇫🇷Dunkerque, France
Clinique Bouchard
🇫🇷Marseille, France
Centre Hospitalier
🇫🇷Perigueux, France
Clinique de L'Yvette
🇫🇷Longjumeau, France
Centre Hospitalalier Universitaire - Hopital Brabois
🇫🇷Nancy, France
Polyclinique Francheville
🇫🇷Perigueux, France
Hopital Fondation Saint Joseph
🇫🇷Marseille, France
Hopital Prive Sainte Blandine
🇫🇷Metz, France
Centre Hospitalier de Roanne
🇫🇷Roanne, France
Clinique Saint Hilaire
🇫🇷Rouen, France
Clinique Guillaume de Varye
🇫🇷Saint Doulchard, France
Clinique de l'Europe
🇫🇷Saint Nazaire, France
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Clinique du Mail
🇫🇷La Rochelle, France