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Intracranial AneurysmNCT06588543

Patient-specific Planning of Minimally Invasive Brain Interventions Based on Vascular-hemodynamic Mapping

An observational study of Intracranial Aneurysm and Arteriovenous Malformations, Cerebral, run by University Hospital, Ghent at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Endovascular procedures for treating brain aneurysms and arteriovenous malformations (AVMs) are becoming increasingly popular due to their less invasive nature and lower risk of complications. However, they still face challenges such as difficult catheter navigation and incomplete embolization. Read more about this study

Who is it for?
Any age
What is being tested?
Endovascular treatment
Type of treatment
Medical device
How many people
500 participants
Where
1 siteBelgium
Study dates
13 Aug 2024to 31 Dec 2030
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: subjects who had or will have endovascular treatment of an intracranial aneurysm or cerebral arteriovenous malformation

Who may be able to join

  • Subjects who are diagnosed with aneurysm or arteriovenous malformation
  • Subjects who are treated (or will be treated) with endovascular embolization and/or arteriovenous coiling
  • During and before/after the subject's intervention, medical images (MRI, 3D rotational angiography, DSA) were collected of the cerebral arterial vascular tree (which can be used to develop patient-specific models), including catheter location and use of contrast fluid to visualize the cerebral to make the arterial tree more visible.

Who cannot join

  • -Procedures during which no imaging was performed

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peter Vanlangenhove, Prof. Dr. contact

+32 9 3323112

peter.vanlangenhove@uzgent.be

Belgium1 site, 1 recruiting
  • University Hospital Ghent

    Ghent, 9000

    Peter Vanlangenhove, PhD, MD, (0)9/332 2938 ext. +32, peter.vanlangenhove@uzgent.be

    Peter Vanlangenhove, PhD, MD

    Recruiting

Other trials in Belgium

About this study

Endovascular procedures for treating brain aneurysms and arteriovenous malformations (AVMs) are becoming increasingly popular due to their less invasive nature and lower risk of complications. However, they still face challenges such as difficult catheter navigation and incomplete embolization.

This study aims to improve the efficiency and safety of endovascular procedures by developing new preoperative planning methodologies. These methodologies involve mapping the cerebral vasculature and creating computational fluid dynamics (CFD) and artificial intelligence (AI) models to simulate blood flow. By using these models, interventional radiologists can better plan catheter navigation and predict embolization outcomes. This could lead to faster, more accurate procedures with reduced radiation exposure for patients.

Read the detailed description

The number of treatments of blood vessels using a catheter inserted into a blood vessel, also known as endovascular treatment, has been increasing over the past decades. There are several advantages associated with this technique, such as that it is less invasive and carries a lower risk of complications. This technique is expected to become the preferred treatment for intracranial aneurysms and arteriovenous malformations (AVMs).

Despite the advantages of endovascular procedures, there are still technical challenges that can affect their effectiveness and safety. In clinical practice, a guidewire (approximately 1.5 to 2.0 m) is directed under fluoroscopic imaging to the specific brain area. Accurately navigating the tip of a passive guidewire by manipulating the proximal end requires many years of experience and can be a cumbersome task even for experienced interventional radiologists. Moreover, navigating the catheter to the target brain area can already take up a large part of the procedure time. A second challenge is the risk of incomplete embolization or recanalization. The risk of incomplete embolization is particularly present in AVMs, as they have a complex structure. The performance of an embolization can cause the hemodynamic in that particular brain region to change, resulting in other preferential flow paths, which can later lead to another embolization procedure. This creates a need for repeated angiographic evaluation, which also leads to longer and more expensive procedures and higher exposure to radiation for the patient. The above challenges show that there is a need for a method that allows for faster and more efficient neurological interventions, with the patient receiving a lower dose of radiation and a higher probability of complete and lasting embolization.

The goal of the study is to develop a new methodology for preoperative planning of catheter navigation and embolization, based on mapping of the cerebral vasculature and modelling of blood flow through the associated arterial vasculature. In cardiology, there are already techniques for guided navigation of the guidewire or other tool without the need for fluoroscopic guidance. In these techniques, the patient-specific vasculature is mapped, with a detailed 3D representation of the vascular network displayed together with tracking of the position of the catheter relative to this map in a correct 3D reference frame. However, these techniques have not yet been extended to neurovascular interventions, since the cerebral vasculature is an intrinsically complex arterial vasculature.

For the current study, there are two main objectives. The first primary objective of this research is to map the cerebral vasculature by quantifying and analysing 3D angiographic data with the aim of assessing the accessibility of the vasculature for catheter navigation and supporting catheter tracking.

The second main objective is to develop and validate computational fluid dynamics (CFD) and artificial intelligence (AI) models of cerebral blood flow, with the aim of supporting preoperative planning. These AI models serve to accelerate the CFD models. The clinical aspect of this study only involves the collection of retrospective and prospective patient data, so there is no additional clinical risk for the patient. Preferably, medical images (cerebral MRI images (resolution: 0.3 - 0.5 mm), 3D rotational angiography (3DRA, resolution: 0.05 - 0.28 mm), biplanar digital subtraction angiography (DSA, resolution: 0.15 - 0.62 mm)), together with a case report form (CRF, including therapy parameters and response). After data collection, patient-specific models of the (accessibility of the) vasculature and fluid distribution in the cerebral blood vessels will be developed on the side of UGent (research groups IbiTech BioMMedA; MEDISIP, Department of Electronics and Information Systems and research group IPI, Department of Telecommunications and Information Processing, both belonging to the Faculty of Engineering and Architecture at UGent). Medical images play a crucial role in the development and validation of these models. Once these models have been validated (including using in vitro models with 3D-printed phantoms), they may also be used in clinical applications in the longer term. Validation of these models in a clinical, interventional setting is not yet applicable for this study.

Being tested
Endovascular treatment
Medical subject headings
Intracranial Aneurysm, Intracranial Arteriovenous Malformations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Endovascular treatmentDevice

    Endovascular treatment

Study groups in NCT06588543
Study groupRoleWhat they receive
Intracranial aneurysmsPatients with at least one intracranial aneurysm that has been coiled
Receives: Device: Endovascular treatment
Arteriovenous malformationsPatients with a cerebral arteriovenous malformation that has been treated by endovascular embolisation
Receives: Device: Endovascular treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy of CFD models

    Correlation coefficient between CFD-predicted and measured blood flow velocity and pressure distribution

    Measured: 4 year

  2. Identification of important procedure parameters

    Identification of key procedure parameters (e.g., properties of embolization agent, procedural actions) using the computational framework.

    Measured: 6 year

  3. Efficiency of AI-enhanced CFD modelling

    Time, sensitivity, specificity, and accuracy of AI models in verifying the acceleration power while maintaining high-quality results.

    Measured: 6 year

  4. Cerebral vasculature mapping

    Development of accurate and efficient image processing methods to support clinical embolization procedures. Evaluation using independent datasets and metrics (e.g., accuracy, precision, recall, F1-score).

    Measured: 6 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start13 Aug 2024
  3. Primary completionDec 2030 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

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
Other
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06588543
Sponsor's protocol ID
ONZ-2024-0129
Status last verified
May 2026
First submitted
13 Aug 2024
Last updated
13 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Intracranial Aneurysm and Arteriovenous Malformations, Cerebral, run by University Hospital, Ghent at 1 site in Belgium.

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 3 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 13 May 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 Belgium. 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 Peter Vanlangenhove, Prof. Dr. (+32 9 3323112, peter.vanlangenhove@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Accuracy of CFD models (time frame: 4 year). The study lists 4 primary outcomes in all. 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 13 May 2026.

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