Abdominal Aortic AneurysmEndurant_WCNNCT06972095
Results Wide and Conical Neck EVAR Procedures
An observational study of Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Abdominal Aortic Aneurysm
- What is being tested?
- EVAR
- Type of treatment
- Surgery or procedure
- How many people
- 268 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2021to 17 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- emergency/rupture procedures
- objection use of data for research
- other prosthesis used for EVAR
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy
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
- Conditions
- Abdominal Aortic Aneurysm
- Being tested
- EVAR
- Keywords
- abdominal aortic aneurysm, EVAR, wide neck, conical neck, hostile neck
- Medical subject headings
- Aortic Aneurysm, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVARProcedure or surgery
endovascular repair of the AAA with the endurant stent graft
| Study group | Role | What they receive |
|---|---|---|
| Wide neck group | patients with an abdominal aortic aneurysm and a wide neck (>28 mm diameter) Receives: Procedure: EVAR | |
| conical neck group | patients with an abdominal aortic aneurysm and a conical neck Receives: Procedure: EVAR | |
| straight neck group | patients with an abdominal aortic aneurysm without a wide or conical neck Receives: Procedure: EVAR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from reinterventions at one year
reintervention-free survival will be evaulated using kaplan meier method
Measured: one year
Secondary outcomes (10)
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
Measured: 10 years
Number of endoleaks
All endoleaks will be registered throughout follow-up and will be presented by type of endoleak.
Measured: 10 year follow-up
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
Measured: 10 year follow-up
the number of patients with an aneurysm rupture during follow-up
all ruptures that occur will be registered including outcome (death or successful repair)
Measured: 10 year follow-up
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
Measured: 10 year follow-up
Number of patients with AAA related mortality
All deaths related to the AAA will be documented
Measured: 10 year follow-up
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
Measured: 10 year follow-up
All-cause mortality
all deaths will be registered regardless their cause
Measured: 10 year follow-up
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
Measured: 30 days
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
Measured: 10 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start23 Mar 2021
- Primary completion15 Apr 2024
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M.M.P.J. Reijnen Vascular Surgeon, Prof. Dr., Principal investigator, Rijnstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06972095
- Sponsor's protocol ID
- 2021-1830
- Acronym
- Endurant_WCN
- Status last verified
- Jan 2026
- First submitted
- 17 Apr 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Performance of the Endurant Endoprosthesis in an Infrarenal Aortic Aneurysm With a Wide or Conical Shaped Infrarenal Neck Anatomy
- ClinicalTrials.gov ID
- NCT06972095
- Acronym / sponsor ID
- Endurant_WCN / 2021-1830
- Conditions
- Abdominal Aortic Aneurysm
- Keywords
- abdominal aortic aneurysm, EVAR, wide neck, conical neck, hostile neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- 23 Mar 2021 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wide neck group | – | Procedure: EVARpatients with an abdominal aortic aneurysm and a wide neck (>28 mm diameter) |
| conical neck group | – | Procedure: EVARpatients with an abdominal aortic aneurysm and a conical neck |
| straight neck group | – | Procedure: EVARpatients with an abdominal aortic aneurysm without a wide or conical neck |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- emergency/rupture procedures
- objection use of data for research
- other prosthesis used for EVAR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EVARendovascular repair of the AAA with the endurant stent graft | Procedure or surgery | Wide neck group, conical neck group, straight neck group |
Primary outcome
Freedom from reinterventions at one year
Time frame: one year
reintervention-free survival will be evaulated using kaplan meier method
10 secondary outcomes
Freedom from reinterventions throughout follow-up (up to ten years)
Time frame: 10 years
Number of endoleaks
Time frame: 10 year follow-up
the number of patients showing aneurysm sac growth
Time frame: 10 year follow-up
the number of patients with an aneurysm rupture during follow-up
Time frame: 10 year follow-up
the number of patients showing stent migration
Time frame: 10 year follow-up
Number of patients with AAA related mortality
Time frame: 10 year follow-up
the number of patients showing proximal fixation failure
Time frame: 10 year follow-up
All-cause mortality
Time frame: 10 year follow-up
The number of patients with 30-day complications
Time frame: 30 days
The number of patients with renal dysfunction/renal occlusion
Time frame: 10 year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M.M.P.J. Reijnen Vascular Surgeon, Prof. Dr. principal investigator
Rijnstate
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from reinterventions at one year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.