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

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ClinicalTrials.gov Identifier: NCT01783184
Recruitment Status : Active, not recruiting
First Posted : February 4, 2013
Last Update Posted : March 3, 2017
Sponsor:
Information provided by (Responsible Party):
Vascutek Ltd.

Study Description
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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.

Condition or disease
Abdominal Aortic Aneurysm

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 Design
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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
Study Start Date : June 2012
Actual Primary Completion Date : October 2013
Estimated Study Completion Date : October 2018

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Overall mortality rate [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ]
  2. 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 ]
  3. Change in diameter of the aneurysm [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ]
  4. 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 ]
  5. Surgical conversion rate [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ]
  6. Rate of endovascular or surgical revisions [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Abdominal Aortic Aneurysm (AAA)
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783184


Locations
France
Clinique Casamance
Aubagne, France, 67091
Clinique Saint Etienne
Bayonne, France, 64100
Clinique Aguilera
Biarritz, France, 64200
Groupe Hospitalier Pellegrin
Bordeaux, France, 33000
Centre Hospitalier Jacques Coeur
Bourges, France, 18020
C.H. Prive Saint Martin
Caen, France, 14000
Infirmerie Protestante
Caluire Et Cuire, France, 69300
Clinique Villette
Dunkerque, France, 59240
Centre Hospitalier Universitaire - Hopital Michallon
Grenoble, France, 38043
Clinique du Mail
La Rochelle, France, 17000
Centre Hospitalier
La Rochelle, France, 17019
Hopital Prive de l'Estuaire
Le Havre, France, 76620
Clinique de L'Yvette
Longjumeau, France, 91160
Clinique Bouchard
Marseille, France, 13006
Hopital Fondation Saint Joseph
Marseille, France, 13285
Hopital Prive Sainte Blandine
Metz, France, 57070
Centre Hospitalier
Moulins, France, 03006
Centre Hospitalalier Universitaire - Hopital Brabois
Nancy, France, 54000
Polyclinique Francheville
Perigueux, France, 24000
Centre Hospitalier
Perigueux, France, 24019
Centre Hospitalier de Roanne
Roanne, France, 42300
Clinique Saint Hilaire
Rouen, France, 76044
Clinique Guillaume de Varye
Saint Doulchard, France, 18230
Clinique de l'Europe
Saint Nazaire, France, 44600
Centre Hospitalier Universitaire - Hopital Civil
Strasbourg, France, 67091
Clinique Vauban
Valenciennes, France, 59300
Sponsors and Collaborators
Vascutek Ltd.
Investigators
Principal Investigator: Professor Dominique Midy Groupe Hospitalier Pellegrin , Bordeaux, France
More Information
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Responsible Party: Vascutek Ltd.
ClinicalTrials.gov Identifier: NCT01783184     History of Changes
Other Study ID Numbers: EPI-ANA01
First Posted: February 4, 2013    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases