Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
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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 |
- 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) |
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 |
Abdominal Aortic Aneurysm (AAA)
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01783184
| 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 | |
| Centre Hospitalier | |
| La Rochelle, France, 17019 | |
| Clinique du Mail | |
| La Rochelle, France, 17000 | |
| 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 | |
| Centre Hospitalier | |
| Perigueux, France, 24019 | |
| Polyclinique Francheville | |
| Perigueux, France, 24000 | |
| 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 | |
| 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: | December 9, 2014 |
| Health Authority: | France: Haute Autorité de santé (HAS) |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Aortic Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 26, 2015