Abdominal Aortic Aneurysms With Challenging AnatomyEAGLENCT01810250
Endurant for Challenging Anatomy: Global Experience Registry
An observational study of Abdominal Aortic Aneurysms With Challenging Anatomy, run by Catharina Ziekenhuis Eindhoven at 1 site in Netherlands.
Trial summary
The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Aortic Aneurysms With Challenging Anatomy
- What is being tested?
- Endurant Stent Graft
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2012to May 2023
- How long will I take part?
- 5 Years
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with abdominal aortic aneurysms (AAAs) with challenging anatomy defined by having one or more of the following measurements: * Proximal necks 5 - 10mm in combination with < 60 degrees infrarenal AND < 45 degrees suprarenal angulation * Proximal necks 10 - 15mm in combination with 60 degrees - 75 degrees infrarenal AND < 60 degrees suprarenal angulation OR in combination with < 75 degrees infrarenal AND 45 degrees - 60 degrees suprarenal angulation * Proximal necks > 15mm in combination with 75 degrees - 90 degrees infrarenal AND < 75 degrees suprarenal angulation OR in combination with < 90 degrees infrarenal AND 60 degrees - 75 degrees suprarenal angulation
Who may be able to join
- Age ≥ 18 years or minimum age as required by local regulations
- Indication for elective EVAR
- Challenging AAA anatomy
- Intention to electively implant the Endurant or Endurant II Stent Graft System©
- Signed informed consent form
Who cannot join
- Subjects with intolerance to contrast media
- Chimneys or fenestrated device procedures
- High probability of non-adherence to physician's follow-up requirements
- Current participation in a concurrent trial that may confound study results
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience
The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.
This study aims at answering two major questions:
- Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
- Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?
- Being tested
- Endurant Stent Graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endurant Stent GraftDevice
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Aortic Aneurysm (Challenging anatomy) | Endovascular aneurysm repair Receives: Device: Endurant Stent Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success
Freedom from:
- Increase of AAA diameter > 5 mm (1 month measurement as baseline)
- Type I\&III endoleaks
- Aneurysm rupture
- Conversion to surgery
- Stent graft migration (>10mm) resulting in SAE or reintervention
- Stent graft occlusion
Measured: 12 months
Secondary outcomes (1)
Helath Related Quality of Life Scores
EQ-5D VAS EQ-5D index
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2013 (estimated)
- Study startNov 2012
- Primary completionJan 2018
- Study completionMay 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Aortic Aneurysms With Challenging AnatomyStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joep Teijink, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01810250
- Sponsor's protocol ID
- EAGLE Registry
- Acronym
- EAGLE
- Status last verified
- Dec 2023
- First submitted
- 12 Feb 2013
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVAR Treatment With the Endurant Stent Graft of Challenging Anatomy in Experienced Hands, the Real World Experience
- ClinicalTrials.gov ID
- NCT01810250
- Acronym / sponsor ID
- EAGLE / EAGLE Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jan 2018 (actual)
- Study completion
- May 2023 (actual)
- First posted
- 13 Mar 2013 (estimated)
- 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.
The Department of Vascular Surgery at Catharina Hospital Eindhoven, The Netherlands initiates the Endurant for Challenging Anatomy: Global Experience (EAGLE) Registry. The aim of this study is to collect clinical information on the performance of the Endurant Stent Graft System for endovascular repair in anatomically challenging aneurysms, and to critically assess whether the current guidelines for anatomic eligibility to endovascular treatment with this system are still applicable. This study aims at creating a database that can be pooled/ compared with the ENGAGE database.
This study aims at answering two major questions:
- Is the technical success rate of successful delivery and deployment of the Endurant (II) similar in anatomically challenging aneurysm?
- Is the successful treatment rate comparable in anatomically challenging aneurysms, or does treatment of these aneurysms lead to more complications and reinterventions?
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Abdominal Aortic Aneurysm (Challenging anatomy) | – | Device: Endurant Stent GraftEndovascular aneurysm repair |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with abdominal aortic aneurysms (AAAs) with challenging anatomy defined by having one or more of the following measurements: * Proximal necks 5 - 10mm in combination with < 60 degrees infrarenal AND < 45 degrees suprarenal angulation * Proximal necks 10 - 15mm in combination with 60 degrees - 75 degrees infrarenal AND < 60 degrees suprarenal angulation OR in combination with < 75 degrees infrarenal AND 45 degrees - 60 degrees suprarenal angulation * Proximal necks > 15mm in combination with 75 degrees - 90 degrees infrarenal AND < 75 degrees suprarenal angulation OR in combination with < 90 degrees infrarenal AND 60 degrees - 75 degrees suprarenal angulation
Key inclusion criteria (5 listed)
- Age ≥ 18 years or minimum age as required by local regulations
- Indication for elective EVAR
- Challenging AAA anatomy
- Intention to electively implant the Endurant or Endurant II Stent Graft System©
- Signed informed consent form
Key exclusion criteria (4 listed)
- Subjects with intolerance to contrast media
- Chimneys or fenestrated device procedures
- High probability of non-adherence to physician's follow-up requirements
- Current participation in a concurrent trial that may confound study results
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 |
|---|---|---|
| Endurant Stent Graft | Device | Abdominal Aortic Aneurysm (Challenging anatomy) |
Primary outcome
Clinical success
Time frame: 12 months
Freedom from: * Increase of AAA diameter > 5 mm (1 month measurement as baseline) * Type I\&III endoleaks * Aneurysm rupture * Conversion to surgery * Stent graft migration (>10mm) resulting in SAE or reintervention * Stent graft occlusion
1 secondary outcome
Helath Related Quality of Life Scores
Time frame: 12 months
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 26 Dec 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Aneurysms With Challenging Anatomy, run by Catharina Ziekenhuis Eindhoven 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 5 inclusion and 4 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 26 Dec 2023. 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?
Clinical success (time frame: 12 months). 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 26 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.