Aneurysm AbdominalVASCULAIDRETRONCT06206369
Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression
An observational study of Aneurysm Abdominal and Peripheral Arterial Disease, run by Amsterdam UMC, location VUmc at 6 sites in 6 countries.
Trial summary
The VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Aneurysm Abdominal, Peripheral Arterial Disease
- How many people
- 11,000 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 31 Oct 2023to 1 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Males and females between 40 and 90 years of age with an abdominal aortic aneurysm and/or peripheral arterial disease.
Who may be able to join
- Males and females
- 40-90 years old,
- Infrarenal, juxtarenal, suprarenal, iliac aneurysms (defined as 1.5x its normal diameter), and mycotic aneurysms.
- Starting AAA diameter >3cm,
- Patients that both have had or did not have interventions or ruptures.
- Males and females,
- 40-90 years old,
- All PAD patients; all Fontaine stages 1,2,3, and 4.
Who cannot join
- Patients with solely an ascending, thoracic, thoracoabdominal (type 1-3) aneurysm.
Trial locations and contacts
6 sites in 6 countries. Contact the study team or a site near you to ask about taking part.
Lotte Rijken, Msc. contact
6 sites in 6 countries
Finland1 site, 1 recruiting
- Recruiting
Hospital District of Helsinki and Uusimaa (HUS)
Helsinki
Riikka Tulamo
Germany1 site, 1 recruiting
- Recruiting
Asklepios kliniken hamburg
Hamburg
Christian Behrendt
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
Kak Khee Yeung
Portugal1 site, 1 recruiting
- Recruiting
University Hospital Center of São João
Porto
Marina Dias-Neto
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Centre of Serbia
Belgrade
Igor Koncar
United Kingdom1 site, 1 recruiting
- Recruiting
Oxford University Hospitals
Oxford
Regent Lee
About this study
The VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). The study plans to gather and analyze data from at least 5000 AAA and 6000 PAD patients, combining existing cohorts and retrospectively collected data. During this project, AI tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. AI prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).
Read the detailed description
To date, it is unknown which abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD) patients will suffer cardiovascular events or in which patients the AAA or PAD will progress. In the VASCULAID project, the VASCULAID-RETRO study aims to leverage data from existing cohorts and retrospectively collected data to develop artificial intelligence (AI) algorithms able to evaluate the risk of cardiovascular events and extent of disease progression.
In order to build and train the algorithms for the predictions, we plan to retrospectively enroll at least 5000 AAA and 6000 PAD patients AI-tools will be applied to the patient data. Automatic anatomical segmentation on images and image analysis on US, CTA and MRI will be performed. Also, algorithms to predict cardiovascular events and AAA or PAD progression based on multi-source data analysis will be developed.
Patient data from European clinical consortium partners is available. This consortium has access to big cohorts with relevant data for the envisioned study that will be used to enrich the existing registries. These data will be used to refine the algorithms developed for the prediction of cardiovascular events and AAA/PAD progression.
- Conditions
- Aneurysm Abdominal, Peripheral Arterial Disease
- Being tested
- No intervention, retrospective study
- Keywords
- Artificial Intelligence, Prediction models, Image analysis, Abdominal Aortic Aneurysms, Peripheral Arterial Disease
- Medical subject headings
- Aortic Aneurysm, Abdominal, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention, retrospective studyOther
No intervention, retrospective study
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Aortic Aneurysm patients | Not described Receives: Other: No intervention, retrospective study | |
| Peripheral Arterial Disease patients | Not described Receives: Other: No intervention, retrospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of disease progression prediction algorithms
The primary goal of this retrospective study is to develop and train algorithms to predict disease progression and risk of cardiovascular events in AAA and PAD patients by leveraging multi-parametric data from 5000 AAA (>1000 in AUMC) and 6000 PAD (>1000 in AUMC) patients from existing cohorts and biobanks.
Measured: 3 years
Secondary outcomes (1)
Internal validation of disease progression prediction algorithms
The secondary objective will be the internal validation of the developed algorithms using data from retrospective cohorts.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start31 Oct 2023
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2029 (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 Aneurysm AbdominalStudies 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
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Technical University of Twente, Universidade do Porto, Centre Hospitalier Universitaire de Nice, Stichting Allai, University of Belgrade, Brightfish Be, Hospital District of Helsinki and Uusimaa, University of Bergen, Asklepios Kliniken Hamburg GmbH, University of Oxford, VINČA INSTITUTE OF NUCLEAR SCIENCES Belgrado
- Responsible party
- Principal investigator, Kak Khee Yeung, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206369
- Sponsor's protocol ID
- 2011279
- Acronym
- VASCULAIDRETRO
- Status last verified
- Sep 2026
- First submitted
- 4 Jan 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rijken L, Zwetsloot S, Smorenburg S, Wolterink J, Isgum I, Marquering H, van Duivenvoorde J, Ploem C, Jessen R, Catarinella F, Lee R, Bera K, Buisan J, Zhang P, Dias-Neto M, Raffort J, Lareyre F, Muller C, Koncar I, Tomic I, Zivkovic M, Djuric T, Stankovic A, Venermo M, Tulamo R, Behrendt CA, Smit N, Schijven M, van den Born BJ, Delewi R, Jongkind V, Ayyalasomayajula V, Yeung KK. Developing Trustworthy Artificial Intelligence Models to Predict Vascular Disease Progression: the VASCUL-AID-RETRO Study Protocol. J Endovasc Ther. 2025 Feb 7:15266028251313963. doi: 10.1177/15266028251313963. Online ahead of print.
PubMed 39921236
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Trustworthy Artificial Intelligence (AI)-Driven Tools to Predict Vascular Disease Risk and Progression
- ClinicalTrials.gov ID
- NCT06206369
- Acronym / sponsor ID
- VASCULAIDRETRO / 2011279
- Conditions
- Aneurysm Abdominal, Peripheral Arterial Disease
- Keywords
- Artificial Intelligence, Prediction models, Image analysis, Abdominal Aortic Aneurysms, Peripheral Arterial Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Technical University of Twente, Universidade do Porto, Centre Hospitalier Universitaire de Nice, Stichting Allai, University of Belgrade, Brightfish Be, Hospital District of Helsinki and Uusimaa, University of Bergen, Asklepios Kliniken Hamburg GmbH, University of Oxford, VINČA INSTITUTE OF NUCLEAR SCIENCES Belgrado
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2029 (estimated)
- First posted
- 16 Jan 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 VASCULAID-RETRO study, within the broader VASCULAID project, aims to create artificial intelligence (AI) algorithms that can predict cardiovascular events and the progression of abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD). The study plans to gather and analyze data from at least 5000 AAA and 6000 PAD patients, combining existing cohorts and retrospectively collected data. During this project, AI tools will be developed to perform automatic anatomical segmentation and analyses on multimodal imaging. AI prediction algorithms will be developed based on multisource data (imaging, medical history, -omics).
Detailed description
To date, it is unknown which abdominal aortic aneurysm (AAA) and peripheral arterial disease (PAD) patients will suffer cardiovascular events or in which patients the AAA or PAD will progress. In the VASCULAID project, the VASCULAID-RETRO study aims to leverage data from existing cohorts and retrospectively collected data to develop artificial intelligence (AI) algorithms able to evaluate the risk of cardiovascular events and extent of disease progression.
In order to build and train the algorithms for the predictions, we plan to retrospectively enroll at least 5000 AAA and 6000 PAD patients AI-tools will be applied to the patient data. Automatic anatomical segmentation on images and image analysis on US, CTA and MRI will be performed. Also, algorithms to predict cardiovascular events and AAA or PAD progression based on multi-source data analysis will be developed.
Patient data from European clinical consortium partners is available. This consortium has access to big cohorts with relevant data for the envisioned study that will be used to enrich the existing registries. These data will be used to refine the algorithms developed for the prediction of cardiovascular events and AAA/PAD progression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Aortic Aneurysm patients | – | Other: No intervention, retrospective study |
| Peripheral Arterial Disease patients | – | Other: No intervention, retrospective study |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females between 40 and 90 years of age with an abdominal aortic aneurysm and/or peripheral arterial disease.
Key inclusion criteria (8 listed)
- Males and females
- 40-90 years old,
- Infrarenal, juxtarenal, suprarenal, iliac aneurysms (defined as 1.5x its normal diameter), and mycotic aneurysms.
- Starting AAA diameter >3cm,
- Patients that both have had or did not have interventions or ruptures.
Key exclusion criteria (1 listed)
- Patients with solely an ascending, thoracic, thoracoabdominal (type 1-3) aneurysm.
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 |
|---|---|---|
| No intervention, retrospective studyNo intervention, retrospective study | Other | Abdominal Aortic Aneurysm patients, Peripheral Arterial Disease patients |
Primary outcome
Development of disease progression prediction algorithms
Time frame: 3 years
The primary goal of this retrospective study is to develop and train algorithms to predict disease progression and risk of cardiovascular events in AAA and PAD patients by leveraging multi-parametric data from 5000 AAA (>1000 in AUMC) and 6000 PAD (>1000 in AUMC) patients from existing cohorts and biobanks.
1 secondary outcome
Internal validation of disease progression prediction algorithms
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Derived from this study: PubMed 39921236Rijken L, Zwetsloot S, Smorenburg S, Wolterink J, Isgum I, Marquering H, van Duivenvoorde J, Ploem C, Jessen R, Catarinella F, Lee R, Bera K, Buisan J, Zhang P, Dias-Neto M, Raffort J, Lareyre F, Muller C, Koncar I, Tomic I, Zivkovic M, Djuric T, Stankovic A, Venermo M, Tulamo R, Behrendt CA, Smit N, Schijven M, van den Born BJ, Delewi R, Jongkind V, Ayyalasomayajula V, Yeung KK. Developing Trustworthy Artificial Intelligence Models to Predict Vascular Disease Progression: the VASCUL-AID-RETRO Study Protocol. J Endovasc Ther. 2025 Feb 7:15266028251313963. doi: 10.1177/15266028251313963. 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.
Lotte Rijken, Msc. contact
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm Abdominal and Peripheral Arterial Disease, run by Amsterdam UMC, location VUmc at 6 sites in 6 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 8 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland, Germany, Netherlands, Portugal, Serbia and 1 more country. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kak Khee Yeung, MD, PhD (+31 6 14278725, k.yeung@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of disease progression prediction algorithms (time frame: 3 years). 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 NCT06206369, 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 5 Oct 2026.