NCT06972095

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2021

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 14, 2025

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

3.1 years

First QC Date

April 17, 2025

Last Update Submit

January 28, 2026

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal aortic aneurysmEVARwide neckconical neckhostile neck

Outcome Measures

Primary Outcomes (1)

  • Freedom from reinterventions at one year

    reintervention-free survival will be evaulated using kaplan meier method

    one year

Secondary Outcomes (10)

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

    10 years

  • Number of endoleaks

    10 year follow-up

  • the number of patients showing aneurysm sac growth

    10 year follow-up

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

    10 year follow-up

  • the number of patients showing stent migration

    10 year follow-up

  • +5 more secondary outcomes

Study Arms (3)

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

EVARPROCEDURE

endovascular repair of the AAA with the endurant stent graft

Wide neck groupconical neck groupstraight neck group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rijnstate

Arnhem, 6515AD, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Officials

  • M.M.P.J. Reijnen Vascular Surgeon, Prof. Dr.

    Rijnstate

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2025

First Posted

May 14, 2025

Study Start

March 23, 2021

Primary Completion

April 15, 2024

Study Completion

April 17, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Locations

NL(1)