Trial record 18 of 84 for:    Open Studies | "Aortic Aneurysm, Abdominal"

Observational Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms (AAA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Vascutek Ltd.
Sponsor:
Collaborator:
Vascutek France
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01783184
First received: January 31, 2013
Last updated: July 8, 2013
Last verified: July 2013
  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:


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 2013
Estimated 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
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

Contacts
Contact: Professor Dominique Midy (33)5 56 79 55 26 dominique.midy@chu-bordeaux.fr

Locations
France
Clinique Casamance Recruiting
Aubagne, France, 67091
Contact: Dr Philippe Rudondy    (33)4 91 88 43 21    Rudondy.philippe@wanadoo.fr   
Contact: Dr Renaud Vidal    (33)4 91 88 43 21    renaud.vidal3@wanadoo.fr   
Principal Investigator: Dr Philippe Rudondy         
Sub-Investigator: Dr Renaud Vidal         
Clinique Saint Etienne Recruiting
Bayonne, France, 64100
Contact: Dr Bruno Mugnier    (33)5 59 50 33 13    bruno.mugnier@numericable.fr   
Principal Investigator: Dr Bruno Mugnier         
Clinique Aguilera Recruiting
Biarritz, France, 64200
Contact: Dr Serge Calen    (33)5 59 22 47 30    sergecalen@wanadoo.fr   
Principal Investigator: Dr Serge Calen         
Groupe Hospitalier Pellegrin Recruiting
Bordeaux, France, 33000
Contact: Professor Dominique Midy    (33) 5 56 79 55 26    dominique.midy@chu-bordeaux.fr   
Principal Investigator: Professor Dominique Midy         
Centre Hospitalier Jacques Coeur Recruiting
Bourges, France, 18020
Contact: Dr Philippe Maillard    (33)2 48 48 57 29    p.maillard@ch-bourges.fr   
Principal Investigator: Dr Philippe Maillard         
C.H. Prive Saint Martin Recruiting
Caen, France, 14000
Contact: Dr Bertrand Caraes    (33)4 91 80 66 64      
Principal Investigator: Dr Bertrand Caraes         
Sub-Investigator: Dr Francis Faroy         
Sub-Investigator: Dr Sebastien Veron         
Infirmerie Protestante Recruiting
Caluire Et Cuire, France, 69300
Contact: Dr Philippe Nicolini    (33)4 72 00 72 00    phnicolini@wanadoo.fr   
Contact: Dr Bertrand Ede    (33)4 72 00 72 00    bertrand.ede@club-internet.fr   
Principal Investigator: Dr Philippe Nicolini         
Sub-Investigator: Dr Bertrand Ede         
Clinique Villette Recruiting
Dunkerque, France, 59240
Contact: Dr Pierre-Louis Ringot    (33) 3 28 23 77 24    plingot@wanadoo.fr   
Contact: Dr Jean-Francois Hermant    (33) 3 28 23 77 90    radiologie.villette@wanadoo.fr   
Principal Investigator: Dr Pierre-Louis Ringot         
Sub-Investigator: Dr Jean-Francois Hermant         
Centre Hospitalier Universitaire - Hopital Michallon Recruiting
Grenoble, France, 38043
Contact: Prof Carmine Sessa    (33)4 76 76 54 75    csessa@chu-grenoble.fr   
Contact: Dr Emmanuel Cochet    (33)4 76 76 54 75    ecochet@chu-grenoble.fr   
Principal Investigator: Prof Carmine Sessa         
Sub-Investigator: Dr Emmanuel Cochet         
Centre Hospitalier Recruiting
La Rochelle, France, 17019
Contact: Dr Sebastien Franco    (33)5 46 45 51 73      
Principal Investigator: Dr Sebastien Franco         
Clinique du Mail Recruiting
La Rochelle, France, 17000
Contact: Dr Jean-Paul Marcade    (33)5 46 00 28 92    marcade.josso@wanadoo.fr   
Principal Investigator: Dr Jean-Paul Marcade         
Hopital Prive de l'Estuaire Recruiting
Le Havre, France, 76620
Contact: Dr Antoine Rossi    (33) 8 25 74 75 76      
Contact: Dr Romain Gaillard    (33) 8 25 74 75 76      
Principal Investigator: Dr Antoine Rossi         
Sub-Investigator: Dr Romain Gaillard         
Clinique de L'Yvette Recruiting
Longjumeau, France, 91160
Contact: Dr Marcel Hoehne    (33) 8 26 30 60 30    hoehnem.129@wanadoo.fr   
Principal Investigator: Dr Marcel Hoehne         
Clinique Bouchard Recruiting
Marseille, France, 13006
Contact: Dr Pierre Bertrand    (33)4 91 17 11 20    pbertrand@gsante.net   
Principal Investigator: Dr Pierre Bertrand         
Hopital Fondation Saint Joseph Recruiting
Marseille, France, 13285
Contact: Dr Nicolas Valerio    (33) 4 91 80 66 64      
Contact: Dr Philippe Rudondy    (33) 2 31 43 30 30      
Principal Investigator: Dr Nicolas Valerio         
Sub-Investigator: Dr Philippe Rudondy         
Sub-Investigator: Dr Renaud Vidal         
Hopital Prive Sainte Blandine Recruiting
Metz, France, 57070
Contact: Dr Nicolas Frisch    (33) 3 87 39 47 89    nicolas.frisch@hp-metz.fr   
Principal Investigator: Dr Nicolas Frisch         
Centre Hospitalier Recruiting
Moulins, France, 03006
Contact: Dr Valerie Elbaz-Kerkad    (33)4 70 35 76 58    chirurgieb@ch.moulins-yseure.fr   
Contact: Dr Ahmed Besbiss    (33)4 70 35 76 58    ahmedbesbiss@yahoo.fr   
Principal Investigator: Dr Valerie Elbaz-Kerkad         
Sub-Investigator: Dr Ahmed Besbiss         
Sub-Investigator: Dr Yssifou Moumouni         
Centre Hospitalalier Universitaire - Hopital Brabois Recruiting
Nancy, France, 54000
Contact: Prof Serguei Malikov    (33)3 83 15 30 64    s.malikov@chu-nancy.fr   
Principal Investigator: Prof Serguei Malikov         
Sub-Investigator: Dr N Settembre         
Centre Hospitalier Recruiting
Perigueux, France, 24019
Contact: Dr Pierre-Jean Bouillanne    (33)5 53 45 25 78    pj.bouillanne@chu-perigueux.fr   
Principal Investigator: Dr Pierre-Jean Bouillanne         
Polyclinique Francheville Recruiting
Perigueux, France, 24000
Contact: Dr Nicolas Diard    (33)5 53 02 13 38    diard.vasculaire@wanadoo.fr   
Contact: Dr Paul Aguilar    (33)5 53 02 13 38    paul.aguilar@wanadoo.fr   
Principal Investigator: Dr Nicolas Diard         
Sub-Investigator: Dr Paul Aguilar         
Centre Hospitalier de Roanne Recruiting
Roanne, France, 42300
Contact: Dr Jean-Pierre De Paepe    (33) 4 77 44 36 99    jean-pierre.de-paepe@chroanne.fr   
Principal Investigator: Dr Jean-Pierre De Paepe         
Clinique Saint Hilaire Recruiting
Rouen, France, 76044
Contact: Dr Thierry Delaunay    (33) 2 35 08 66 91    t.delaunay@wanadoo.fr   
Principal Investigator: Dr Thierry Delaunay         
Clinique Guillaume de Varye Recruiting
Saint Doulchard, France, 18230
Contact: Dr Olivier Briand         
Principal Investigator: Dr Olivier Briand         
Clinique de l'Europe Recruiting
Saint Nazaire, France, 44600
Contact: Dr Frederic Villapadierna    (33)2 51 16 10 70    fvillapadierna@polyclinique-europe.com   
Principal Investigator: Dr Frederic Villapadierna         
Centre Hospitalier Universitaire - Hopital Civil Recruiting
Strasbourg, France, 67091
Contact: Prof Nabil Chakfe    (33)3 69 55 08 88    nabil.chakfe@chru-strasbourg.fr   
Principal Investigator: Prof Nabil Chakfe         
Sub-Investigator: Prof Fabien Thaveau         
Sub-Investigator: Dr Yamick Georg         
Clinique Vauban Recruiting
Valenciennes, France, 59300
Contact: Dr Assem Mikati    (33) 3 27 32 42 52    ethierache@nordnet.fr   
Principal Investigator: Dr Assem Mikati         
Sponsors and Collaborators
Vascutek Ltd.
Vascutek France
Investigators
Principal Investigator: Professor Dominique Midy Groupe Hospitalier Pellegrin , Bordeaux, France
  More Information

No publications provided

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: July 8, 2013
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 July 29, 2014