Clinical trial NCT01783184: Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
Official title: Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: Vascutek Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-04
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Abdominal Aortic Aneurysm (AAA)

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.

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

Primary outcomes:
measure: Overall mortality rate
timeFrame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
measure: Mortality rate related to rupture of the aneurysm and relationship to the stent
timeFrame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
measure: Change in diameter of the aneurysm
timeFrame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
measure: Rate of Type I, II and III endoleaks
timeFrame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
measure: Surgical conversion rate
timeFrame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
measure: Rate of endovascular or surgical revisions
timeFrame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aubagne
country: France
facility: Clinique Casamance
city: Bayonne
country: France
facility: Clinique Saint Etienne
city: Biarritz
country: France
facility: Clinique Aguilera
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Bourges
country: France
facility: Centre Hospitalier Jacques Coeur
city: Caen
country: France
facility: C.H. Prive Saint Martin
city: Caluire Et Cuire
country: France
facility: Infirmerie Protestante
city: Dunkerque
country: France
facility: Clinique Villette
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire - Hopital Michallon
city: La Rochelle
country: France
facility: Clinique du Mail
city: La Rochelle
country: France
facility: Centre Hospitalier
city: Le Havre
country: France
facility: Hopital Prive de l'Estuaire
city: Longjumeau
country: France
facility: Clinique de L'Yvette
city: Marseille
country: France
facility: Clinique Bouchard
city: Marseille
country: France
facility: Hopital Fondation Saint Joseph
city: Metz
country: France
facility: Hopital Prive Sainte Blandine
city: Moulins
country: France
facility: Centre Hospitalier
city: Nancy
country: France
facility: Centre Hospitalalier Universitaire - Hopital Brabois
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Perigueux
country: France
facility: Centre Hospitalier
city: Roanne
country: France
facility: Centre Hospitalier de Roanne
city: Rouen
country: France
facility: Clinique Saint Hilaire
city: Saint Doulchard
country: France
facility: Clinique Guillaume de Varye
city: Saint Nazaire
country: France
facility: Clinique de l'Europe
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire - Hopital Civil
city: Valenciennes
country: France
facility: Clinique Vauban
Study officials:
affiliation: Groupe Hospitalier Pellegrin , Bordeaux, France
name: Professor Dominique Midy
role: PRINCIPAL_INVESTIGATOR
References: