Clinical trial NCT06972095: The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy
Official title: The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Aortic Aneurysm
Keywords: abdominal aortic aneurysm
EVAR
wide neck
conical neck
hostile neck
Lead sponsor: Rijnstate Hospital
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 268
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Freedom from reinterventions at one year
timeFrame: one year
Secondary outcomes:
measure: Freedom from reinterventions throughout follow-up (up to ten years)
timeFrame: 10 years
measure: Number of endoleaks
timeFrame: 10 year follow-up
measure: the number of patients showing aneurysm sac growth
timeFrame: 10 year follow-up
measure: the number of patients with an aneurysm rupture during follow-up
timeFrame: 10 year follow-up
measure: the number of patients showing stent migration
timeFrame: 10 year follow-up
measure: Number of patients with AAA related mortality
timeFrame: 10 year follow-up
measure: the number of patients showing proximal fixation failure
timeFrame: 10 year follow-up
measure: All-cause mortality
timeFrame: 10 year follow-up
measure: The number of patients with 30-day complications
timeFrame: 30 days
measure: The number of patients with renal dysfunction/renal occlusion
timeFrame: 10 year follow-up
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate
Study officials:
affiliation: Rijnstate
name: M.M.P.J. Reijnen Vascular Surgeon, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: