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The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy (Endurant_WCN)

R

Rijnstate Hospital

Status

Completed

Conditions

Abdominal Aortic Aneurysm

Treatments

Procedure: EVAR

Study type

Observational

Funder types

Other

Identifiers

NCT06972095
2021-1830

Details and patient eligibility

About

Retrospective single centre observational cohort study of patients who underwent an elective infrarenal abdominal aortic aneurysm repair, from January 2011 to January 2020.

Full 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

Enrollment

268 patients

Sex

All

Volunteers

No Healthy Volunteers

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

Trial design

268 participants in 3 patient groups

Wide neck group
Description:
patients with an abdominal aortic aneurysm and a wide neck (\>28 mm diameter)
Treatment:
Procedure: EVAR
conical neck group
Description:
patients with an abdominal aortic aneurysm and a conical neck
Treatment:
Procedure: EVAR
straight neck group
Description:
patients with an abdominal aortic aneurysm without a wide or conical neck
Treatment:
Procedure: EVAR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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