Abdominal Aortic Aneurysm
Conditions
Keywords
abdominal aortic aneurysm, EVAR, wide neck, conical neck, hostile neck
Brief summary
Retrospective single centre observational cohort study of patients who underwent an elective infrarenal abdominal aortic aneurysm repair, from January 2011 to January 2020.
Detailed description
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: * Endoleaks * Aneurysm sac growth * Aneurysm rupture * Stent migration * AAA-related mortality * All-cause mortality * Procedural time * 30-day complications * Renal dysfunction/renal occlusion * Proximal fixation failure
Interventions
PROCEDUREEVAR
endovascular repair of the AAA with the endurant stent graft
Sponsors
Rijnstate Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
* emergency/rupture procedures * objection use of data for research * other prosthesis used for EVAR
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from reinterventions at one year | one year | reintervention-free survival will be evaulated using kaplan meier method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Freedom from reinterventions throughout follow-up (up to ten years) | 10 years | Reintervention-free survival throughout all available follow-up will be evaluated using kaplan-meier methods |
| Number of endoleaks | 10 year follow-up | All endoleaks will be registered throughout follow-up and will be presented by type of endoleak. |
| the number of patients showing aneurysm sac growth | 10 year follow-up | 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 |
| the number of patients with an aneurysm rupture during follow-up | 10 year follow-up | all ruptures that occur will be registered including outcome (death or successful repair) |
| the number of patients showing stent migration | 10 year follow-up | 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 |
| Number of patients with AAA related mortality | 10 year follow-up | All deaths related to the AAA will be documented |
| the number of patients showing proximal fixation failure | 10 year follow-up | 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 |
| All-cause mortality | 10 year follow-up | all deaths will be registered regardless their cause |
| The number of patients with 30-day complications | 30 days | All complications during the first 30 days will be registered related to the procedure and will be listed for the different types of complications |
| The number of patients with renal dysfunction/renal occlusion | 10 year follow-up | all clinical relevant declines in renal function will be documented, including renal artery stenosis or occlusion |
Countries
Netherlands
Contacts
PRINCIPAL_INVESTIGATORM.M.P.J. Reijnen Vascular Surgeon, Prof. Dr.
Rijnstate
Outcome results
None listed