Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01783184 |
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Recruitment Status
:
Active, not recruiting
First Posted
: February 4, 2013
Last Update Posted
: March 3, 2017
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| Condition or disease |
|---|
| Abdominal Aortic Aneurysm |
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 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 |
- Overall mortality rate [ Time Frame: 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 [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ]
- Change in diameter of the aneurysm [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ]
- 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 ]
- Surgical conversion rate [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ]
- Rate of endovascular or surgical revisions [ Time Frame: Post-op (within 30 days), 6 months, 12 months and then annually up to 5 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
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
| 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 | |
| Principal Investigator: | Professor Dominique Midy | Groupe Hospitalier Pellegrin , Bordeaux, France |
| 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:
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Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |