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

NCT ID: NCT01783184

Last Updated: 2020-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2019-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Abdominal Aortic Aneurysm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vascutek Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Professor Dominique Midy

Role: PRINCIPAL_INVESTIGATOR

Groupe Hospitalier Pellegrin , Bordeaux, France

Locations

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Clinique Casamance

Aubagne, , France

Site Status

Clinique Saint Etienne

Bayonne, , France

Site Status

Clinique Aguilera

Biarritz, , France

Site Status

Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

Centre Hospitalier Jacques Coeur

Bourges, , France

Site Status

C.H. Prive Saint Martin

Caen, , France

Site Status

Infirmerie Protestante

Caluire-et-Cuire, , France

Site Status

Clinique Villette

Dunkirk, , France

Site Status

Centre Hospitalier Universitaire - Hopital Michallon

Grenoble, , France

Site Status

Clinique du Mail

La Rochelle, , France

Site Status

Centre Hospitalier

La Rochelle, , France

Site Status

Hopital Prive de l'Estuaire

Le Havre, , France

Site Status

Clinique de L'Yvette

Longjumeau, , France

Site Status

Clinique Bouchard

Marseille, , France

Site Status

Hopital Fondation Saint Joseph

Marseille, , France

Site Status

Hopital Prive Sainte Blandine

Metz, , France

Site Status

Centre Hospitalier

Moulins, , France

Site Status

Centre Hospitalalier Universitaire - Hopital Brabois

Nancy, , France

Site Status

Polyclinique Francheville

Périgueux, , France

Site Status

Centre Hospitalier

Périgueux, , France

Site Status

Centre Hospitalier de Roanne

Roanne, , France

Site Status

Clinique Saint Hilaire

Rouen, , France

Site Status

Clinique Guillaume de Varye

Saint-Doulchard, , France

Site Status

Clinique de l'Europe

Saint-Nazaire, , France

Site Status

Centre Hospitalier Universitaire - Hopital Civil

Strasbourg, , France

Site Status

Clinique Vauban

Valenciennes, , France

Site Status

Countries

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France

Other Identifiers

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EPI-ANA01

Identifier Type: -

Identifier Source: org_study_id

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