- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01783184
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdo Minal Aortic Aneurysms
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Aubagne, France, 67091
- Clinique Casamance
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Bayonne, France, 64100
- Clinique Saint Etienne
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Biarritz, France, 64200
- Clinique Aguiléra
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Bordeaux, France, 33000
- Groupe Hospitalier Pellegrin
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Bourges, France, 18020
- Centre Hospitalier Jacques Coeur
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Caen, France, 14000
- C.H. Prive Saint Martin
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Caluire Et Cuire, France, 69300
- Infirmerie Protestante
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Dunkerque, France, 59240
- Clinique Villette
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Grenoble, France, 38043
- Centre Hospitalier Universitaire - Hopital Michallon
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La Rochelle, France, 17000
- Clinique du Mail
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La Rochelle, France, 17019
- Centre Hospitalier
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Le Havre, France, 76620
- Hôpital Privé de l'Estuaire
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Longjumeau, France, 91160
- Clinique de L'Yvette
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Marseille, France, 13006
- Clinique Bouchard
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Marseille, France, 13285
- Hopital Fondation Saint Joseph
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Metz, France, 57070
- Hopital Prive Sainte Blandine
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Moulins, France, 03006
- Centre Hospitalier
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Nancy, France, 54000
- Centre Hospitalalier Universitaire - Hopital Brabois
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Perigueux, France, 24000
- Polyclinique Francheville
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Perigueux, France, 24019
- Centre Hospitalier
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Roanne, France, 42300
- Centre Hospitalier de Roanne
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Rouen, France, 76044
- Clinique Saint Hilaire
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Saint Doulchard, France, 18230
- Clinique Guillaume De Varye
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Saint Nazaire, France, 44600
- Clinique de l'Europe
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Strasbourg, France, 67091
- Centre Hospitalier Universitaire - Hopital Civil
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Valenciennes, France, 59300
- Clinique Vauban
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall mortality rate
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Mortality rate related to rupture of the aneurysm and relationship to the stent
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Change in diameter of the aneurysm
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Rate of Type I, II and III endoleaks
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Surgical conversion rate
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Rate of endovascular or surgical revisions
Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Professor Dominique Midy, Groupe Hospitalier Pellegrin , Bordeaux, France
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPI-ANA01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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