Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms

Abdominal Aortic Aneurysm Clinical Trial

Official title:

Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01783184
• Other study ID #: EPI-ANA01
• Status: Completed
• Start date: June 2012
• Est. completion date: December 2019

Study information

• Verified date: October 2020
• Source: Vascutek Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: December 2019
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Locations

Country	Name	City	State
France	Clinique Casamance	Aubagne
France	Clinique Saint Etienne	Bayonne
France	Clinique Aguilera	Biarritz
France	Groupe Hospitalier Pellegrin	Bordeaux
France	Centre Hospitalier Jacques Coeur	Bourges
France	C.H. Prive Saint Martin	Caen
France	Infirmerie Protestante	Caluire Et Cuire
France	Clinique Villette	Dunkerque
France	Centre Hospitalier Universitaire - Hopital Michallon	Grenoble
France	Centre Hospitalier	La Rochelle
France	Clinique du Mail	La Rochelle
France	Hopital Prive de l'Estuaire	Le Havre
France	Clinique de L'Yvette	Longjumeau
France	Clinique Bouchard	Marseille
France	Hopital Fondation Saint Joseph	Marseille
France	Hopital Prive Sainte Blandine	Metz
France	Centre Hospitalier	Moulins
France	Centre Hospitalalier Universitaire - Hopital Brabois	Nancy
France	Centre Hospitalier	Perigueux
France	Polyclinique Francheville	Perigueux
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	Centre Hospitalier Universitaire - Hopital Civil	Strasbourg
France	Clinique Vauban	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Vascutek Ltd.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall mortality rate		Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Primary	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
Primary	Change in diameter of the aneurysm		Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Primary	Rate of Type I, II and III endoleaks		Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Primary	Surgical conversion rate		Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Primary	Rate of endovascular or surgical revisions		Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years