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Retrospective single centre observational cohort study of patients who underwent an elective infrarenal abdominal aortic aneurysm repair, from January 2011 to January 2020.
Objective: To evaluate the performance of the Endurant endoprothesis in patients with a wide or conical shaped neck anatomy after elective abdominal aortic aneurysm repair.
Inclusion: Patients who underwent elective infrarenal abdominal aortic aneurysm repair with the Endurant endograft between January 2011 until January 2020 in Rijnstate, Arnhem, the Netherlands.
Primary endpoint: Freedom from reinterventions at one year.
Secondary outcomes:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Wide neck group | patients with an abdominal aortic aneurysm and a wide neck (>28 mm diameter) |
| |
| conical neck group | patients with an abdominal aortic aneurysm and a conical neck |
| |
| straight neck group | patients with an abdominal aortic aneurysm without a wide or conical neck |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EVAR | Procedure | endovascular repair of the AAA with the endurant stent graft |
|
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from reinterventions at one year | reintervention-free survival will be evaulated using kaplan meier method | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Freedom from reinterventions throughout follow-up (up to ten years) | Reintervention-free survival throughout all available follow-up will be evaluated using kaplan-meier methods | 10 years |
| Number of endoleaks |
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Inclusion Criteria:
All patients with an elective infrarenal endovascular abdominal aortic aneurysm repair with the Endurant endoprothesis between January 2011 till January 2020 in the Rijnstate hospital, Arnhem, the Netherlands.
Exclusion Criteria:
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All patients with an elective infrarenal endovascular abdominal aortic aneurysm repair with the Endurant endoprothesis between January 2011 till January 2020 in the Rijnstate hospital, Arnhem, the Netherlands.
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| Name | Affiliation | Role |
|---|---|---|
| M.M.P.J. Reijnen Vascular Surgeon, Prof. Dr. | Rijnstate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate | Arnhem | 6515AD | Netherlands |
On request we can decide if data can be shared; due to country and hospital policy, data transfer agreements need to be in place
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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All endoleaks will be registered throughout follow-up and will be presented by type of endoleak.
| 10 year follow-up |
| the number of patients showing aneurysm sac growth | Sac growth is defined as growth over 5 mm and will be presented for 1 year follow-up, 5 years follow-up and 10 year follow-up | 10 year follow-up |
| the number of patients with an aneurysm rupture during follow-up | all ruptures that occur will be registered including outcome (death or successful repair) | 10 year follow-up |
| the number of patients showing stent migration | stent migration will be documented in mm and will be presented for 1 year follow-up, 5 years follow-up and 10 year follow-up | 10 year follow-up |
| Number of patients with AAA related mortality | All deaths related to the AAA will be documented | 10 year follow-up |
| the number of patients showing proximal fixation failure | proximal fixation failure is defined as yes if type 1 endoleak or stent migration or aneurysm sac growth will occur and will be presented for 1 year follow-up, 5 years follow-up and 10 year follow-up | 10 year follow-up |
| All-cause mortality | all deaths will be registered regardless their cause | 10 year follow-up |
| The number of patients with 30-day complications | All complications during the first 30 days will be registered related to the procedure and will be listed for the different types of complications | 30 days |
| The number of patients with renal dysfunction/renal occlusion | all clinical relevant declines in renal function will be documented, including renal artery stenosis or occlusion | 10 year follow-up |
| D001018 |
| Aortic Diseases |