Unruptured Intracranial AneurysmEPICAVCNCT06705452
MRI Analysis in the Growth of Cerebral Aneurysms
A study testing Additional 4D Flow MRI or additional 4D Flow sequence in people with Unruptured Intracranial Aneurysm, run by CHU de Reims at 1 site in France.
Trial summary
An intracranial aneurysm is defined as a localized dilatation of the cerebral arteries, which can potentially lead to rupture and subsequent hemorrhagic stroke. The mechanisms by which aneurysms develop and grow remain unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Intracranial Aneurysm
- What is being tested?
- Additional 4D Flow MRI or additional 4D Flow sequence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jul 2026to 8 Jul 2032
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with one or more unruptured intracranial aneurysms followed up at the participating center. Patients may have other ruptured and/or treated aneurysms
- Patient older than 18 years
- Patient consenting to participate to the study
- Patient enrolled in the national healthcare insurance program
Who cannot join
- Patients who have already received surgical or endovascular treatment for all their aneurysm(s), or who are due to receive such treatment in less than 2 months.
- Patients with only ruptured aneurysm(s)
- Patients with arteriovenous malformations (treated or untreated)
- Patients with a contraindication to MRI
- Patients with an allergy to one of the contrast agents (Iodixanol, Gadoteric acid)
- Pregnant or breast-feeding patients
- Patients protected by law.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Damien JOLLY
Reims, 51100
Sébastien SOIZE, 03 10 73 62 17 ext. 0033, ssoize@chu-reims.fr
Christophe PORTEFAIX, 03 26 78 94 82, cportefaix@chu-reims.fr
About this study
Official title: 4D-MRI Morphological Study of Local Growth in Cerebral Aneurysms
An intracranial aneurysm is defined as a localized dilatation of the cerebral arteries, which can potentially lead to rupture and subsequent hemorrhagic stroke. The mechanisms by which aneurysms develop and grow remain unknown. The objective of this project is to utilize MRI, a routine non-invasive examination for detecting and following up aneurysms, to identify visually and quantitatively an aneurysm growth and relevant biomarkers that can predict the risk of aneurysm development.
Read the detailed description
An intracranial aneurysm is defined as a malformation of the cerebral arteries, which is characterized by a focal dilatation of the arterial wall.
The prevalence of intracranial aneurysms in the general population is estimated to be between 3% and 6%, as reported in the literature. Although the rupture rate is relatively low, at approximately 1-2% per year per aneurysm, this risk is increased if the aneurysm is growing. The morbi-mortality rates associated with meningeal or subarachnoid hemorrhage are high, with an estimated 60% mortality rate within three months and 30% of patients remaining permanently disabled. It is therefore imperative to monitor the evolution of aneurysms in order to assess the risk of complications and guide therapeutic decisions.
The mechanism(s) of aneurysm formation and growth remain unknown. Aneurysms form in a zone of weakness in the artery wall as a result of hemodynamic variations.
Methods of risk stratification and therapeutic planning (endovascular treatment (coil) or surgical treatment (clip)) are currently based solely on empirical and statistical parameters such as the size or shape of the aneurysm, the patient's smoking habits or alcoholism.
The fundamental principle underlying the treatment of cerebral aneurysms with the objective of reducing the risk of long-term rupture is the exclusion of the aneurysm from the arterial circulation. This confirm the impact of hemodynamics on the risk of aneurysm rupture.
Although arteriography remains the gold standard for follow-up of aneurysms, it is an invasive and irradiative examination that is increasingly being replaced by a non-invasive routine exam, Magnetic Resonance Imaging (MRI).
Currently, there is no consensus regarding the indications for the treatment of unruptured intracranial aneurysms, which are generally asymptomatic. Successful outcome of the project would improve physical understanding of aneurysmal pathology, enabling the decision-making process regarding treatment to be adapted to the specific characteristics of the aneurysm in question. This would provide additional arguments for proposing or not proposing expensive endovascular treatment of aneurysms, which is often proposed as a first-line treatment.
- Conditions
- Unruptured Intracranial Aneurysm
- Being tested
- Additional 4D Flow MRI or additional 4D Flow sequence
- Keywords
- Aneurysm Growth, Unruptured Intracranial aneurysm, Cerebral Aneurysm, Vascular Diseases, Intracranial Arterial Diseases, Intracranial Aneurysm
- Medical subject headings
- Intracranial Aneurysm, Vascular Diseases, Intracranial Arterial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional 4D Flow MRI or additional 4D Flow sequenceOther
Additional 4D Flow MRI or additional 4D Flow sequence
| Study group | Role | What they receive |
|---|---|---|
| Patients with unruptured and untreated aneurysms | Experimental | Patients in radiology for the first diagnostic evaluation or the follow-up of unruptured and untreated aneurysms. Receives: Other: Additional 4D Flow MRI or additional 4D Flow sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the shape of the aneurysm
Millimetric quantification of the three-dimensional evolution of the shape of the aneurysm sac, calculated using a computer algorithm
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start8 Jul 2026
- Primary completion7 Feb 2032 (estimated)
- Study completion8 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unruptured Intracranial AneurysmStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 281 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705452
- Sponsor's protocol ID
- PO24101
- Acronym
- EPICAVC
- Status last verified
- Aug 2026
- First submitted
- 22 Nov 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4D-MRI Morphological Study of Local Growth in Cerebral Aneurysms
- ClinicalTrials.gov ID
- NCT06705452
- Acronym / sponsor ID
- EPICAVC / PO24101
- Conditions
- Unruptured Intracranial Aneurysm
- Keywords
- Aneurysm Growth, Unruptured Intracranial aneurysm, Cerebral Aneurysm, Vascular Diseases, Intracranial Arterial Diseases, Intracranial Aneurysm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 281 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 8 Jul 2026 (actual)
- Primary completion
- 7 Feb 2032 (estimated)
- Study completion
- 8 Jul 2032 (estimated)
- First posted
- 26 Nov 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.
An intracranial aneurysm is defined as a localized dilatation of the cerebral arteries, which can potentially lead to rupture and subsequent hemorrhagic stroke. The mechanisms by which aneurysms develop and grow remain unknown. The objective of this project is to utilize MRI, a routine non-invasive examination for detecting and following up aneurysms, to identify visually and quantitatively an aneurysm growth and relevant biomarkers that can predict the risk of aneurysm development.
Detailed description
An intracranial aneurysm is defined as a malformation of the cerebral arteries, which is characterized by a focal dilatation of the arterial wall.
The prevalence of intracranial aneurysms in the general population is estimated to be between 3% and 6%, as reported in the literature. Although the rupture rate is relatively low, at approximately 1-2% per year per aneurysm, this risk is increased if the aneurysm is growing. The morbi-mortality rates associated with meningeal or subarachnoid hemorrhage are high, with an estimated 60% mortality rate within three months and 30% of patients remaining permanently disabled. It is therefore imperative to monitor the evolution of aneurysms in order to assess the risk of complications and guide therapeutic decisions.
The mechanism(s) of aneurysm formation and growth remain unknown. Aneurysms form in a zone of weakness in the artery wall as a result of hemodynamic variations.
Methods of risk stratification and therapeutic planning (endovascular treatment (coil) or surgical treatment (clip)) are currently based solely on empirical and statistical parameters such as the size or shape of the aneurysm, the patient's smoking habits or alcoholism.
The fundamental principle underlying the treatment of cerebral aneurysms with the objective of reducing the risk of long-term rupture is the exclusion of the aneurysm from the arterial circulation. This confirm the impact of hemodynamics on the risk of aneurysm rupture.
Although arteriography remains the gold standard for follow-up of aneurysms, it is an invasive and irradiative examination that is increasingly being replaced by a non-invasive routine exam, Magnetic Resonance Imaging (MRI).
Currently, there is no consensus regarding the indications for the treatment of unruptured intracranial aneurysms, which are generally asymptomatic. Successful outcome of the project would improve physical understanding of aneurysmal pathology, enabling the decision-making process regarding treatment to be adapted to the specific characteristics of the aneurysm in question. This would provide additional arguments for proposing or not proposing expensive endovascular treatment of aneurysms, which is often proposed as a first-line treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with unruptured and untreated aneurysms | Experimental | Other: Additional 4D Flow MRI or additional 4D Flow sequencePatients in radiology for the first diagnostic evaluation or the follow-up of unruptured and untreated aneurysms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with one or more unruptured intracranial aneurysms followed up at the participating center. Patients may have other ruptured and/or treated aneurysms
- Patient older than 18 years
- Patient consenting to participate to the study
- Patient enrolled in the national healthcare insurance program
Key exclusion criteria (7 listed)
- Patients who have already received surgical or endovascular treatment for all their aneurysm(s), or who are due to receive such treatment in less than 2 months.
- Patients with only ruptured aneurysm(s)
- Patients with arteriovenous malformations (treated or untreated)
- Patients with a contraindication to MRI
- Patients with an allergy to one of the contrast agents (Iodixanol, Gadoteric acid)
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 |
|---|---|---|
| Additional 4D Flow MRI or additional 4D Flow sequenceAdditional 4D Flow MRI or additional 4D Flow sequence | Other | Patients with unruptured and untreated aneurysms |
Primary outcome
Evolution of the shape of the aneurysm
Time frame: At 3 years
Millimetric quantification of the three-dimensional evolution of the shape of the aneurysm sac, calculated using a computer algorithm
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 7 Aug 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional 4D Flow MRI or additional 4D Flow sequence in people with Unruptured Intracranial Aneurysm, run by CHU de Reims at 1 site in France.
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 4 inclusion and 7 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 7 Aug 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 France. 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 Sébastien SOIZE (03 10 73 62 17 ext. 0033, ssoize@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the shape of the aneurysm (time frame: At 3 years). 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 7 Aug 2026.