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CompletedNCT06972095Endurant_WCNUpdated Jan 29, 2026

Results Wide and Conical Neck EVAR Procedures

An observational study in Abdominal Aortic Aneurysm, sponsored by Rijnstate Hospital. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2026-01-29.

Sponsored by Rijnstate Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
268
Sex
All
01

Study summary

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

Read the 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
02

Conditions studied

  • Abdominal Aortic Aneurysm

Keywords

  • abdominal aortic aneurysm
  • EVAR
  • wide neck
  • conical neck
  • hostile neck
03

In context

Aortic Aneurysm, Abdominal

473 studies on the registry are indexed under Aortic Aneurysm, Abdominal; 100 are open to participants now.

This study's enrollment of 268 is above the median of 166 across 220 observational studies indexed under Aortic Aneurysm, Abdominal.

Browse Aortic Aneurysm, Abdominal studies →

Lead sponsor

Rijnstate Hospital is the lead sponsor of 127 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

  • emergency/rupture procedures
  • objection use of data for research
  • other prosthesis used for EVAR
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
268 participants (actual)
Patient registry
No

Groups and cohorts

  • Wide neck group

    patients with an abdominal aortic aneurysm and a wide neck (\>28 mm diameter)

    Procedure: EVAR

  • conical neck group

    patients with an abdominal aortic aneurysm and a conical neck

    Procedure: EVAR

  • straight neck group

    patients with an abdominal aortic aneurysm without a wide or conical neck

    Procedure: EVAR

Interventions

  • ProcedureEVAR

    endovascular repair of the AAA with the endurant stent graft

06

What researchers measure

Primary outcomes

  1. Freedom from reinterventions at one year

    reintervention-free survival will be evaulated using kaplan meier method

    Time frame: one year

Secondary outcomes

  1. 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

    Time frame: 10 years

  2. Number of endoleaks

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

    Time frame: 10 year follow-up

  3. 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

    Time frame: 10 year follow-up

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

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

    Time frame: 10 year follow-up

  5. 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

    Time frame: 10 year follow-up

  6. Number of patients with AAA related mortality

    All deaths related to the AAA will be documented

    Time frame: 10 year follow-up

  7. 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

    Time frame: 10 year follow-up

  8. All-cause mortality

    all deaths will be registered regardless their cause

    Time frame: 10 year follow-up

  9. 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

    Time frame: 30 days

  10. 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

    Time frame: 10 year follow-up

07

Study locations

1 site
  • Rijnstate
    Arnhem, 6515AD, Netherlands
08

References and documents

Individual participant data

Plan to share: Undecided — On request we can decide if data can be shared; due to country and hospital policy, data transfer agreements need to be in place

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06972095
Lead sponsor
Rijnstate Hospital
Responsible party
Sponsor
First posted
May 14, 2025
Start date
Mar 23, 2021
Primary completion
Apr 15, 2024
Completion
Apr 17, 2025
Last update
Jan 29, 2026

Study contacts

M.M.P.J. Reijnen Vascular Surgeon, Prof. Dr.
principal investigator · Rijnstate

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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