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Study of Abdominal Aortic Stent Grafts in the Treatment of Infrarenal Abdominal Aortic Aneurysms
This study is ongoing, but not recruiting participants.
Sponsor:
Vascutek Ltd.
Information provided by (Responsible Party):
Vascutek Ltd.
ClinicalTrials.gov Identifier:
NCT01783184
First received: January 31, 2013
Last updated: March 2, 2017
Last verified: March 2017
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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 |
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 ]
- 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 ]
| 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 (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
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.
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: | March 2, 2017 |
| Individual Participant Data | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on June 23, 2017