AAA - Abdominal Aortic AneurysmARTinEVARNCT06250998
Prediction of Abdominal Aortic Aneurysm Shrinkage After Stent-placement With Artificial Intelligence
An observational study of AAA - Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 5 sites in 2 countries.
Trial summary
The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AAA - Abdominal Aortic Aneurysm
- How many people
- 1,000 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 3 Apr 2024to Jun 2024
- 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, electively treated with EVAR for an infrarenal AAA, will be included from the hospital records of 5 experienced vascular centers, 4 sites in the Netherlands and 1 site in Sweden.
Who may be able to join
- Age ≥ 18 years;
- Elective, initially technically successful (as described by the ESVS guidelines11), infrarenal EVAR for unruptured infrarenal AAA;
- Implanted endograft is a Gore Excluder, Medtronic Endurant, Cook Zenith, Cordis Incraft, Endologix AFX, Jotec E-Tegra, or Vascutek Anaconda endograft;
- Follow-up of the AAA of at least one year with imaging of the same modality as the preoperative imaging;
- Axial reconstructions of preoperative CT angiography available, preferably in the arterial phase and with 3 mm or smaller slice thickness.
Who cannot join
- Patients with ruptured or symptomatic AAA;
- Patients that were treated with fenestrated or branched endografts, iliac branched devices, non-CE marked devices within trial setting, other endografts (EVAS cases) or chimney procedures;
- Acute procedures;
- Reintervention before one year follow-up;
- Revision cases after previous open or endovascular aneurysm repair of an AAA;
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Netherlands4 sites, 4 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Kak Khee Yeung, MD PhD, 0031880057282, contact@radarconsortium.com
- Recruiting
Rijnstate Hospital
Arnhem, Non US/Canada, 6800 TA
Rianne E van Rijswijk, MSc, 0031880057282, vascularsurgery@rijnstate.nl
Michel MP Reijnen, MD PhD
- Recruiting
Medisch Spectrum Twente
Enschede
Bob Geelkerken, MD PhD, 0031880057282, contact@radarconsortium.com
- Recruiting
Universitair Medisch Centrum Groningen
Groningen
Clark Zeebregts, 0031880057282, contact@radarconsortium.com
Sweden1 site, 1 recruiting
- Not yet recruiting
Karolinksa Institutet
Stockholm
Marko Bogdanovic, MD, 0031880057282, contact@radarconsortium.com
Joy Roy, MD PhD
About this study
Official title: Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair With Artificial Intelligence
The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Keywords
- AAA, aneurysm shrinkage, EVAR, aneurysm remodeling, artificial intelligence, AI
- Medical subject headings
- Aortic Aneurysm, Abdominal
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction model for AAA shrinkage
A prediction model to predict AAA shrinkage one-year after EVAR, it can consist of multiple CTA-scans and/or clinical data.
Measured: Preoperative, peroperative and postoperative (until 1-year visit) data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start3 Apr 2024
- Primary completionMay 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AAA - 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
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen, Amsterdam UMC, location VUmc, Medisch Spectrum Twente, Karolinska Institutet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06250998
- Sponsor's protocol ID
- 2021-1986
- Acronym
- ARTinEVAR
- Status last verified
- Apr 2024
- First submitted
- 1 Feb 2024
- Last updated
- 11 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
van Rijswijk RE, Bogdanovic M, Roy J, Yeung KK, Zeebregts CJ, Geelkerken RH, Groot Jebbink E, Wolterink JM, Reijnen MMPJ. Multimodal Artificial Intelligence Model for Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair ( the ART in EVAR study). J Endovasc Ther. 2025 Jan 30:15266028251314359. doi: 10.1177/15266028251314359. Online ahead of print.
PubMed 39882767
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair With Artificial Intelligence
- ClinicalTrials.gov ID
- NCT06250998
- Acronym / sponsor ID
- ARTinEVAR / 2021-1986
- Conditions
- AAA - Abdominal Aortic Aneurysm
- Keywords
- AAA, aneurysm shrinkage, EVAR, aneurysm remodeling, artificial intelligence, AI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- University Medical Center Groningen, Amsterdam UMC, location VUmc, Medisch Spectrum Twente, Karolinska Institutet
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Feb 2024 (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.
The goal of this observational study is to find out what factors contribute to a good treatment outcome in patients who have received a stent for their dilation of the main abdominal artery (abdominal aortic aneurysm or AAA). The primary goal of this study is to build a prediction model for abdominal aortic aneurysm shrinkage one year after the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients, electively treated with EVAR for an infrarenal AAA, will be included from the hospital records of 5 experienced vascular centers, 4 sites in the Netherlands and 1 site in Sweden.
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- Elective, initially technically successful (as described by the ESVS guidelines11), infrarenal EVAR for unruptured infrarenal AAA;
- Implanted endograft is a Gore Excluder, Medtronic Endurant, Cook Zenith, Cordis Incraft, Endologix AFX, Jotec E-Tegra, or Vascutek Anaconda endograft;
- Follow-up of the AAA of at least one year with imaging of the same modality as the preoperative imaging;
- Axial reconstructions of preoperative CT angiography available, preferably in the arterial phase and with 3 mm or smaller slice thickness.
Key exclusion criteria (5 listed)
- Patients with ruptured or symptomatic AAA;
- Patients that were treated with fenestrated or branched endografts, iliac branched devices, non-CE marked devices within trial setting, other endografts (EVAS cases) or chimney procedures;
- Acute procedures;
- Reintervention before one year follow-up;
- Revision cases after previous open or endovascular aneurysm repair of an AAA;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prediction model for AAA shrinkage
Time frame: Preoperative, peroperative and postoperative (until 1-year visit) data
A prediction model to predict AAA shrinkage one-year after EVAR, it can consist of multiple CTA-scans and/or clinical data.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2024.
- Derived from this study: PubMed 39882767van Rijswijk RE, Bogdanovic M, Roy J, Yeung KK, Zeebregts CJ, Geelkerken RH, Groot Jebbink E, Wolterink JM, Reijnen MMPJ. Multimodal Artificial Intelligence Model for Prediction of Abdominal Aortic Aneurysm Shrinkage After Endovascular Repair ( the ART in EVAR study). J Endovasc Ther. 2025 Jan 30:15266028251314359. doi: 10.1177/15266028251314359. Online ahead of print.
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AAA - Abdominal Aortic Aneurysm, run by Rijnstate Hospital at 5 sites in 2 countries.
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 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands, Sweden. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rianne E van Rijswijk, MSc (0031880057282, contact@radarconsortium.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction model for AAA shrinkage (time frame: Preoperative, peroperative and postoperative (until 1-year visit) data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06250998, which also lists 1 linked publication.
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 11 Apr 2024.