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OpenTrials
Completed

NCT Number: NCT06972095

Results Wide and Conical Neck EVAR Procedures

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

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Key information

Conditions

Abdominal Aortic Aneurysm Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Diseases Cardiovascular Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Rijnstate

Arnhem, 6515AD, Netherlands

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EVAR

Procedure

endovascular repair of the AAA with the endurant stent graft

Primary outcomes

  1. Freedom from reinterventions at one year

    Time frame: one year

    reintervention-free survival will be evaulated using kaplan meier method

Secondary outcomes

  1. Freedom from reinterventions throughout follow-up (up to ten years)

    Time frame: 10 years

    Reintervention-free survival throughout all available follow-up will be evaluated using kaplan-meier methods

  2. Number of endoleaks

    Time frame: 10 year follow-up

    All endoleaks will be registered throughout follow-up and will be presented by type of endoleak.

  3. the number of patients showing aneurysm sac growth

    Time frame: 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

  4. the number of patients with an aneurysm rupture during follow-up

    Time frame: 10 year follow-up

    all ruptures that occur will be registered including outcome (death or successful repair)

  5. the number of patients showing stent migration

    Time frame: 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

  6. Number of patients with AAA related mortality

    Time frame: 10 year follow-up

    All deaths related to the AAA will be documented

  7. the number of patients showing proximal fixation failure

    Time frame: 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

  8. All-cause mortality

    Time frame: 10 year follow-up

    all deaths will be registered regardless their cause

  9. The number of patients with 30-day complications

    Time frame: 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

  10. The number of patients with renal dysfunction/renal occlusion

    Time frame: 10 year follow-up

    all clinical relevant declines in renal function will be documented, including renal artery stenosis or occlusion

Sponsors and collaborators

Lead sponsor

Rijnstate Hospital

Other

Registry information

Official study title

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

Acronym: Endurant_WCN

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
May 14, 2025
Registry last updated
Jan 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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