Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms - Full Text View

Purpose

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
Abdominal Aortic Aneurysm


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

Genetic and Rare Diseases Information Center resources: Abdominal Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by Vascutek Ltd.:

Primary Outcome Measures:

Overall mortality rate [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change in diameter of the aneurysm [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Surgical conversion rate [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]
Rate of endovascular or surgical revisions [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ] [ Designated as safety issue: No ]


Estimated Enrollment:	180
Study Start Date:	June 2012
Estimated Study Completion Date:	October 2018
Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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.

Vascutek France

Investigators


Principal Investigator:	Professor Dominique Midy	Groupe Hospitalier Pellegrin , Bordeaux, France

More Information


Responsible Party:	Vascutek Ltd.
ClinicalTrials.gov Identifier:	NCT01783184 History of Changes
Other Study ID Numbers:	EPI-ANA01
Study First Received:	January 31, 2013
Last Updated:	December 9, 2014
Health Authority:	France: Haute Autorité de santé (HAS)

Additional relevant MeSH terms:


Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal	Vascular Diseases Cardiovascular Diseases Aortic Diseases

ClinicalTrials.gov processed this record on September 28, 2016