Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
1 other identifier
observational
180
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 31, 2013
CompletedFirst Posted
Study publicly available on registry
February 4, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedOctober 6, 2020
October 1, 2020
1.3 years
January 31, 2013
October 5, 2020
Conditions
Outcome Measures
Primary Outcomes (6)
Overall mortality rate
Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Mortality rate related to rupture of the aneurysm and relationship to the stent
Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Change in diameter of the aneurysm
Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of Type I, II and III endoleaks
Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Surgical conversion rate
Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Rate of endovascular or surgical revisions
Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years
Eligibility Criteria
Abdominal Aortic Aneurysm (AAA)
You may qualify if:
- Any patient implanted with the Vascutek Anaconda™ Stent Graft System for the treatment of a non-ruptured infrarenal Abdominal Aortic Aneurysm (AAA)
You may not qualify if:
- Patients for whom clinical follow-up is impossible and cannot return for check-up visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vascutek Ltd.lead
Study Sites (26)
Clinique Casamance
Aubagne, 67091, France
Clinique Saint Etienne
Bayonne, 64100, France
Clinique Aguilera
Biarritz, 64200, France
Groupe Hospitalier Pellegrin
Bordeaux, 33000, France
Centre Hospitalier Jacques Coeur
Bourges, 18020, France
C.H. Prive Saint Martin
Caen, 14000, France
Infirmerie Protestante
Caluire-et-Cuire, 69300, France
Clinique Villette
Dunkirk, 59240, France
Centre Hospitalier Universitaire - Hopital Michallon
Grenoble, 38043, France
Clinique du Mail
La Rochelle, 17000, France
Centre Hospitalier
La Rochelle, 17019, France
Hopital Prive de l'Estuaire
Le Havre, 76620, France
Clinique de L'Yvette
Longjumeau, 91160, France
Clinique Bouchard
Marseille, 13006, France
Hopital Fondation Saint Joseph
Marseille, 13285, France
Hopital Prive Sainte Blandine
Metz, 57070, France
Centre Hospitalier
Moulins, 03006, France
Centre Hospitalalier Universitaire - Hopital Brabois
Nancy, 54000, France
Polyclinique Francheville
Périgueux, 24000, France
Centre Hospitalier
Périgueux, 24019, France
Centre Hospitalier de Roanne
Roanne, 42300, France
Clinique Saint Hilaire
Rouen, 76044, France
Clinique Guillaume de Varye
Saint-Doulchard, 18230, France
Clinique de l'Europe
Saint-Nazaire, 44600, France
Centre Hospitalier Universitaire - Hopital Civil
Strasbourg, 67091, France
Clinique Vauban
Valenciennes, 59300, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Professor Dominique Midy
Groupe Hospitalier Pellegrin , Bordeaux, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2013
First Posted
February 4, 2013
Study Start
June 1, 2012
Primary Completion
October 1, 2013
Study Completion
December 1, 2019
Last Updated
October 6, 2020
Record last verified: 2020-10