Cerebral Aneurysm UnrupturedANXIFLOWNCT06914414
Impact of Life-size 3D Model on Patient Anxiety During Intracranial Aneurysms Embolization in Interventional Neuroradiology.
A study testing Using the flow model in cerebral aneurysm embolization in people with Cerebral Aneurysm Unruptured, run by University Hospital, Caen at 1 site in France.
Trial summary
Intracranial aneurysm is a malformation of the cerebral arteries, identifying with a focal dilatation of the wall of an intracranial artery. This pathology is a fragility of the arterial wall which dilates abnormally creating ≪ a pocket ≫ where blood circulates under pressure. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cerebral Aneurysm Unruptured
- What is being tested?
- Using the flow model in cerebral aneurysm embolization
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2025to 2 May 2028
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient (aged 18-70) with cerebral aneurysm pathology
- Affiliated to the French social security system
- Patient informed of the study and having signed the informed consent form
- Patient who speaks and understands French
Who cannot join
- Patient > 70 years of age (benefit/risk balance of preventive treatment against treatment) treatment)
- Patient under guardianship, curatorship, safeguard of justice or legal protection
- Mentally handicapped patient
- Patient with severe psychiatric pathology
- Patient unable to communicate in French
- Patients receiving premedication
- Patient under 18 years
- Blind patient
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
CHU Caen
Caen, France, 14000
Camille LINSKI, 33+651086074, linski-ca@chu-caen.fr
About this study
Official title: Interventional Neuroradiology Evaluation of a 3D Silicon Flow Model Representing the Aorto Cervicoencephalic Arterial Tree, Enabling the Patient to Simulate the Entire Procedure During the Preoperative Consultation
Intracranial aneurysm is a malformation of the cerebral arteries, identifying with a focal dilatation of the wall of an intracranial artery. This pathology is a fragility of the arterial wall which dilates abnormally creating ≪ a pocket ≫ where blood circulates under pressure. Due to their parietal fragility, aneurysms can grow or rupture. In addition, certain factors such as chronic arterial hypertension, smoking and chronic alcohol intoxication favor the risk of aneurysm rupture or growth. Cerebral aneurysm rupture has a serious prognosis: 10% of patients die before reaching hospital, 25% die within 24 hours, and 40-49% die within 3 months. Interventional neuroradiology offers treatment via an endovascular approach, by obstructing the aneurysm with coils and stents navigating within the arteries. This operation is not without risk of death or per-procedural stroke. In France, it is estimated that 5 to 7 patients per 100,000 of the population suffer a ruptured aneurysm, which means around 5,000 new cases every year. This figure does not take into account patients who die before accessing medical services.
Interventional neuroradiology is a little-known discipline. Lack of knowledge about the activity, the professionals involved and the technologies involved, leads to anxiety among patients.
Read more
Moreover, neurological pathologies are often physically undetectable. The investigators note a high degree of anxiety among patients on arrival at the department.However, it is difficult to explain the examination without support.That's why it would be interesting to build a simulation tool.
The investigators note a high degree of anxiety among patients on arrival at the department. However, it is difficult to explain the examination without support. That's why it would be interesting to build a simulation tool.
simulation tool to help explain the procedure: a 3D printer model of the vessels of a full-scale silicone model called the flow model, to be presented at the paramedical consultation for the experimental group. This will enable the patient to visualize the procedure and play an active role in it. The patient will therefore be able to benefit from all the information the procedure and the practices involved, understanding not only how the puncture is made and where, but also how it is arrived at. the aneurysm and how it is treated. In addition, visualizing the procedure will help patients to avoid the unknown, and make it easier to manage their anxiety.
The flow model enables visualization of aneurysmal pathology in a simplified, concrete and didactic way for patients and the general public.
At present, flow models of cerebral aneurysms have already been evaluated by some teams with a view to improving the information provided to the patient, in a non-randomized fashion and partially covering the operation.
To our knowledge, there is no flow model reproducing the entire endovascular operative pathway from the puncture site (femoral or radial approach), the aorta and the graft to the aorta.
the aorta, then the cervical arteries through to the cerebral aneurysm, has yet to be created and used.
The major advantage of this modelization would be to simulate the entire procedure during the consultation, from puncture to placement of the stent and coils occluding the aneurysm. This project is particularly innovative, as it enables the patient to rationalize the procedure, potentially reducing his or her state of anxiety, and putting the patient and paramedical team in a practical situation to face up to the inherent risks of the operation. In addition, flow model simulation will enable the paramedical team to be trained in the practice of interventions. The ANXIFLOW project will therefore form the basis of a new handling training course for the continuing education of radiology technicians.
This will involve preparing the radiology technicians to assist the doctor, preparing the equipment, disinfecting and laying the operating drapes, and anticipating the doctor's needs: prepared coils, micro-catheters, perfusion bag and purge circuit, etc.
- Conditions
- Cerebral Aneurysm Unruptured
- Being tested
- Using the flow model in cerebral aneurysm embolization
- Keywords
- aneurysm, anxiety, flow model
- Medical subject headings
- Aneurysm, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using the flow model in cerebral aneurysm embolizationProcedure or surgery
Since the 1970s-1980s, surgical techniques for intracranial aneurysms have evolved. In recent years, endovascular embolization of aneurysms has demonstrated a better approach to the pathology, as well as better results in terms of both vital prognosis, but also in terms of quality of life (disability, logical disorders, etc.). However, this treatment modality remains little known to the general public, and generates a high level of anxiety for patients.
The anxiety of these patients could be reduced by the addition of a paramedical consultation and the use of a flow model to explain and visualize the procedure.
The study will include 72 patients per group (i.e. a total of 144 patients, with a 10% loss of blood pressure) to achieve a two-point reduction in the anxiety score measured by the APAIS grid.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Patient undergoing embolization of an unruptured aneurysm with standard management (medical consultation with the physician) + a paramedical consultation with oral information and explanations by the radiology technician (one week before the procedure) |
| Experimental | Experimental | Patient undergoing embolization of unruptured aneurysm with standard management (medical consultation with the physician) + paramedical consultation with oral information and presentation of the flow model by the radiology technician (one week before the procedure) Receives: Procedure: Using the flow model in cerebral aneurysm embolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
APAIS scale
To compare the level of preoperative anxiety according to the APAIS scale before and after the preoperative paramedical consultation between a group of patients receiving standard information (control group) and a group of patients who also benefited from the flow model surgical simulation (experimental group).
Measured: Before and after paramedical consultation (Day less 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start2 May 2025 (estimated)
- Primary completion2 May 2028 (estimated)
- Study completion2 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Aneurysm UnrupturedStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah HEMERY, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914414
- Sponsor's protocol ID
- 24-0030 chu caen
- Other IDs
- CHU CAEN
- Acronym
- ANXIFLOW
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Neuroradiology Evaluation of a 3D Silicon Flow Model Representing the Aorto Cervicoencephalic Arterial Tree, Enabling the Patient to Simulate the Entire Procedure During the Preoperative Consultation
- ClinicalTrials.gov ID
- NCT06914414
- Acronym / sponsor ID
- ANXIFLOW / 24-0030 chu caen
- Conditions
- Cerebral Aneurysm Unruptured
- Keywords
- aneurysm, anxiety, flow model
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- 2 May 2025 (estimated)
- Primary completion
- 2 May 2028 (estimated)
- Study completion
- 2 May 2028 (estimated)
- First posted
- 6 Apr 2025 (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.
Intracranial aneurysm is a malformation of the cerebral arteries, identifying with a focal dilatation of the wall of an intracranial artery. This pathology is a fragility of the arterial wall which dilates abnormally creating ≪ a pocket ≫ where blood circulates under pressure. Due to their parietal fragility, aneurysms can grow or rupture. In addition, certain factors such as chronic arterial hypertension, smoking and chronic alcohol intoxication favor the risk of aneurysm rupture or growth. Cerebral aneurysm rupture has a serious prognosis: 10% of patients die before reaching hospital, 25% die within 24 hours, and 40-49% die within 3 months. Interventional neuroradiology offers treatment via an endovascular approach, by obstructing the aneurysm with coils and stents navigating within the arteries. This operation is not without risk of death or per-procedural stroke. In France, it is estimated that 5 to 7 patients per 100,000 of the population suffer a ruptured aneurysm, which means around 5,000 new cases every year. This figure does not take into account patients who die before accessing medical services.
Interventional neuroradiology is a little-known discipline. Lack of knowledge about the activity, the professionals involved and the technologies involved, leads to anxiety among patients.
Moreover, neurological pathologies are often physically undetectable. The investigators note a high degree of anxiety among patients on arrival at the department.However, it is difficult to explain the examination without support.That's why it would be interesting to build a simulation tool.
The investigators note a high degree of anxiety among patients on arrival at the department. However, it is difficult to explain the examination without support. That's why it would be interesting to build a simulation tool.
simulation tool to help explain the procedure: a 3D printer model of the vessels of a full-scale silicone model called the flow model, to be presented at the paramedical consultation for the experimental group. This will enable the patient to visualize the procedure and play an active role in it. The patient will therefore be able to benefit from all the information the procedure and the practices involved, understanding not only how the puncture is made and where, but also how it is arrived at. the aneurysm and how it is treated. In addition, visualizing the procedure will help patients to avoid the unknown, and make it easier to manage their anxiety.
The flow model enables visualization of aneurysmal pathology in a simplified, concrete and didactic way for patients and the general public.
At present, flow models of cerebral aneurysms have already been evaluated by some teams with a view to improving the information provided to the patient, in a non-randomized fashion and partially covering the operation.
To our knowledge, there is no flow model reproducing the entire endovascular operative pathway from the puncture site (femoral or radial approach), the aorta and the graft to the aorta.
the aorta, then the cervical arteries through to the cerebral aneurysm, has yet to be created and used.
The major advantage of this modelization would be to simulate the entire procedure during the consultation, from puncture to placement of the stent and coils occluding the aneurysm. This project is particularly innovative, as it enables the patient to rationalize the procedure, potentially reducing his or her state of anxiety, and putting the patient and paramedical team in a practical situation to face up to the inherent risks of the operation. In addition, flow model simulation will enable the paramedical team to be trained in the practice of interventions. The ANXIFLOW project will therefore form the basis of a new handling training course for the continuing education of radiology technicians.
This will involve preparing the radiology technicians to assist the doctor, preparing the equipment, disinfecting and laying the operating drapes, and anticipating the doctor's needs: prepared coils, micro-catheters, perfusion bag and purge circuit, etc.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Patient undergoing embolization of an unruptured aneurysm with standard management (medical consultation with the physician) + a paramedical consultation with oral information and explanations by the radiology technician (one week before the procedure) |
| Experimental | Experimental | Procedure: Using the flow model in cerebral aneurysm embolizationPatient undergoing embolization of unruptured aneurysm with standard management (medical consultation with the physician) + paramedical consultation with oral information and presentation of the flow model by the radiology technician (one week before the procedure) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient (aged 18-70) with cerebral aneurysm pathology
- Affiliated to the French social security system
- Patient informed of the study and having signed the informed consent form
- Patient who speaks and understands French
Key exclusion criteria (8 listed)
- Patient > 70 years of age (benefit/risk balance of preventive treatment against treatment) treatment)
- Patient under guardianship, curatorship, safeguard of justice or legal protection
- Mentally handicapped patient
- Patient with severe psychiatric pathology
- Patient unable to communicate in French
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 |
|---|---|---|
| Using the flow model in cerebral aneurysm embolizationSince the 1970s-1980s, surgical techniques for intracranial aneurysms have evolved. In recent years, endovascular embolization of aneurysms has demonstrated a better approach to the pathology, as well as better results in terms of both vital prognosis, but also in terms of quality of life (disability, logical disorders, etc.). However, this treatment modality remains little known to the general public, and generates a high level of anxiety for patients. The anxiety of these patients could be reduced by the addition of a paramedical consultation and the use of a flow model to explain and visualize the procedure. The study will include 72 patients per group (i.e. a total of 144 patients, with a 10% loss of blood pressure) to achieve a two-point reduction in the anxiety score measured by the APAIS grid. | Procedure or surgery | Experimental |
Primary outcome
APAIS scale
Time frame: Before and after paramedical consultation (Day less 7)
To compare the level of preoperative anxiety according to the APAIS scale before and after the preoperative paramedical consultation between a group of patients receiving standard information (control group) and a group of patients who also benefited from the flow model surgical simulation (experimental group).
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 6 Apr 2025.
Related trials for Cerebral Aneurysm Unruptured
RecruitingObservational study
A Study of Choydar Flow-Directed Mesh Stent in the Treatment of Unruptured Intracranial Aneurysms
Intracranial Aneurysm
Not yet recruiting
Effect of Bilateral Greater Occipital Nerve Block on Headache After Intracranial Aneurysm Coiling
Intracranial Aneurysm, Postoperative Pain
RecruitingObservational study
Evaluation of Intestinal Microbiota Implication in Ruptured Intracranial Aneurysm
Intracranial Sacciform Aneurysm
Not yet recruitingPhase 4
Efficacy and Safety of Methylprednisolone After Flow-Diverter Stent Implantation in Unruptured Intracranial Aneurysms
Unruptured Intracranial Aneurysms, Cerebrovascular Event
Recruiting
Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)
Aneurysm, Aneurysm, Intracranial
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.
Sarah HEMERY principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using the flow model in cerebral aneurysm embolization in people with Cerebral Aneurysm Unruptured, run by University Hospital, Caen 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 8 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: opening soon, as of the sponsor's last update on 6 Apr 2025. 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 Sarah HEMERY (33+699309976, hemery-s@chu-caen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
APAIS scale (time frame: Before and after paramedical consultation (Day less 7)). 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 6 Apr 2025.