Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Abdominal Aortic Aneurysm (AAA)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Professor Dominique Midy | Groupe Hospitalier Pellegrin , Bordeaux, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Casamance | Aubagne | 67091 | France | |||
| Clinique Saint Etienne |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Bayonne |
| 64100 |
| France |
| Clinique Aguilera | Biarritz | 64200 | France |
| Groupe Hospitalier Pellegrin | Bordeaux | 33000 | France |
| Centre Hospitalier Jacques Coeur | Bourges | 18020 | France |
| C.H. Prive Saint Martin | Caen | 14000 | France |
| Infirmerie Protestante | Caluire-et-Cuire | 69300 | France |
| Clinique Villette | Dunkirk | 59240 | France |
| Centre Hospitalier Universitaire - Hopital Michallon | Grenoble | 38043 | France |
| Clinique du Mail | La Rochelle | 17000 | France |
| Centre Hospitalier | La Rochelle | 17019 | France |
| Hopital Prive de l'Estuaire | Le Havre | 76620 | France |
| Clinique de L'Yvette | Longjumeau | 91160 | France |
| Clinique Bouchard | Marseille | 13006 | France |
| Hopital Fondation Saint Joseph | Marseille | 13285 | France |
| Hopital Prive Sainte Blandine | Metz | 57070 | France |
| Centre Hospitalier | Moulins | 03006 | France |
| Centre Hospitalalier Universitaire - Hopital Brabois | Nancy | 54000 | France |
| Polyclinique Francheville | Périgueux | 24000 | France |
| Centre Hospitalier | Périgueux | 24019 | France |
| Centre Hospitalier de Roanne | Roanne | 42300 | France |
| Clinique Saint Hilaire | Rouen | 76044 | France |
| Clinique Guillaume de Varye | Saint-Doulchard | 18230 | France |
| Clinique de l'Europe | Saint-Nazaire | 44600 | France |
| Centre Hospitalier Universitaire - Hopital Civil | Strasbourg | 67091 | France |
| Clinique Vauban | Valenciennes | 59300 | France |
| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001018 | Aortic Diseases |
Not provided
Not provided