Unruptured Intracranial AneurysmESSNAINCT07433075
Assessment of the Clinical and Economic Impact of Sim&Size, a Simulation Software for Implantable Devices Used in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study.
A study testing 3D simulation of placement of neurovascular implantable medical device and Manual planning of endovascular procedure in people with Unruptured Intracranial Aneurysm, run by Sim&Cure at 6 sites in France.
Trial summary
In recent years, endovascular treatment of intracranial aneurysms has seen remarkable growth, now surpassing traditional surgical approaches in terms of frequency of use. However, this transition to endovascular methods is not without its challenges. 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?
- 3D simulation of placement of neurovascular implantable medical device and Manual planning of endovascular procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 6 sitesFrance
- Study dates
- 10 Apr 2026to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged ≥18 years planned to be treated endovascularly for unruptured intracranial aneurysms.
- Planned implantable device models is available in the Sim\&Size simulation database and used following their approved indications.
- Affiliated with the French social security system.
- Signed the information and consent form
Who cannot join
- Patients scheduled to undergo endovascular treatment with stents only
- Patients presenting for treatment of a ruptured aneurysm
- Patients who have already been treated in the planned deployment area and whose previous treatment presents a potential contact with the new implant.
- Giant intracranial aneurysm resulting in poor-quality reconstruction in the potential deployment area of the implant during 3DRA acquisition
- Presence of artifacts on the 3DRA in the potential deployment area of the implant
- Patients with multiple aneurysms whose treatment is planned during a single procedure and who require separate individual therapeutic strategies. Examples of individual therapeutic strategies excluded from the study: placement of two separate flow diverters without telescopic technique, individual coiling of each aneurysm.
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- Patients for whom pre-planning was performed using Sim\&Cure software prior to patient randomization.
- Pregnant or breastfeeding women.
- Patients under guardianship or conservatorship.
- Emergency situations.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU d'Angers
Angers, 49100
Jean-Baptiste Girot, Dr
- Recruiting
CHU de Bordeaux
Bordeaux, 33000
Gaultier Marnat, Dr
- Recruiting
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, 94270
Laurent Spelle, Dr
- Not yet recruiting
Hôpital de La Timone
Marseille, 13005
Jean-François Hak, Dr
- Not yet recruiting
Fondation Rothschild
Paris, 75019
Raphaël Blanc, Dr
- Not yet recruiting
CHU de Reims
Reims, 51092
Laurent Pierrot, Dr
About this study
In recent years, endovascular treatment of intracranial aneurysms has seen remarkable growth, now surpassing traditional surgical approaches in terms of frequency of use. However, this transition to endovascular methods is not without its challenges. This type of procedure requires careful selection of the device to be implanted, a decision that is still based on manual two-dimensional measurements. This method is questionable, as it does not always take into account the complexity and specificities of certain aneurysms, where three-dimensional geometry can play a crucial role. As a result, these procedures carry significant risks, such as the need for additional maneuvers to remove or reposition devices, or even deploy another support device, which potentially increases the risk of perioperative complications, the duration of surgery, and the amount of radiation required for imaging. Beyond the impact on the patient, these complications also result in additional costs for the healthcare system, expenses that could likely be avoided if more precise and appropriate tools were used from the outset of the procedure. In this context, optimizing the choice of endovascular devices could have both clinical and economic impacts. Innovative technology such as Sim\&Size, which supports healthcare professionals in their therapeutic decisions and choice of the appropriate endovascular device, should therefore improve the effectiveness and efficiency of endovascular treatments.
Sim\&Size is a Software as a Medical Device (SaMD) intended to provide a 3D view of the final placement of neurovascular implantable medical devices of the following types: flow diverters, intrasaccular devices, stent devices, and coils. It uses an actual image of the patient produced by 3D rotational angiography. It offers physicians the possibility of simulating the deployment of implantable medical devices in the artery to be treated and predicts the final placement and the extent of apposition of the implant. Sim\&Size has CE marking and FDA clearance.
This study is a prospective, randomized, multicenter study whose main objective is to show that the use of Sim\&Size during the standard endovascular procedure, compared with a standard endovascular procedure without Sim\&Size, reduces both the actual costs of the hospital stay and the rate of perioperative complications.
- Conditions
- Unruptured Intracranial Aneurysm
- Being tested
- 3D simulation of placement of neurovascular implantable medical device, Manual planning of endovascular procedure
- Keywords
- endovascular, 3D simulation, healthcare costs, intracranial aneurysm, software
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D simulation of placement of neurovascular implantable medical deviceOther
Using the Sim\&Size software to obtain a 3D view of the final placement of neurovascular implantable medical devices of the following types: flow diverters, intrasaccular devices, stent devices, and coils, using an actual image of the patient produced by 3D rotational angiography. Used in the treatment of intracranial aneurysm.
Manual planning of endovascular procedureOther
Manual planning of endovascular procedure using 2D images for placement of implantable medical devices for treatment of intracranial aneurysm.
| Study group | Role | What they receive |
|---|---|---|
| Manual planning | Active comparator | Investigator will use manual two-dimensional measurements to assess which neurovascular implantable medical device to use to treat the intracranial aneurysm. Receives: Other: Manual planning of endovascular procedure |
| Sim&Size planning | Experimental | Investigator will use Sim\&Size software, which allows for three dimensional representation of the aneurysm and for simulation of the placement of different types of devices, to support the choice of the neurovascular implantable medical device used to treat the intracranial aneurysm. Receives: Other: 3D simulation of placement of neurovascular implantable medical device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Sim&Size use during endovascular procedure on healthcare costs
The main objective is to compare the use of Sim\&Size during a standard endovascular procedure versus manual planning in modifying the healthcare costs of the hospital stay.
This objective will be demonstrated through the use of the following criteria:
-Difference in average direct hospital costs between the two groups.
The two primary outcomes measures will be analyzed in a sequential hierarchical manner
Measured: From enrollment to the end of follow-up at 6 months
Impact of Sim&Size use during endovascular procedure on perioperative complications
The main objective is to compare the use of Sim\&Size during a standard endovascular procedure versus manual planning in modifying the rate of perioperative complications. This objective will be demonstrated through the use of the following criteria: Difference in the rate of perioperative complications.
The two primary outcomes measures will be analyzed in a sequential hierarchical manner
Measured: From enrollment to the end of follow-up at 6 months
Secondary outcomes (13)
Demonstrate a change in average hospital costs by type of endovascular device used
Demonstrate a change in average healthcare costs by type of endovascular device used (flow diverter, coils or intra-saccular device)
Measured: From enrollment to end of follow-up at 6 months
Demonstrate a change in rate of perioperative complications by type of endovascular device used
Demonstrate a change in rate of perioperative complications by type of endovascular device used
Measured: From surgery to the end of follow-up (6 months)
Change in the rate of aneurysm(s) recurrence
Demonstrate a change in the rate of aneurysm(s) recurrence at six months. Recurrence is defined as inadequate occlusion of the aneurysm on follow-up imaging at six months.
Measured: At 6 months post surgery
Change in operating time
Demonstrate a change in operating time during the endovascular procedure (in minutes)
Measured: From beginning to end of surgery (maximum of 24 hours)
Change of device deployment time
Demonstrate a change in the device deployment time during the endovascular procedure (in minutes)
Measured: From beginning to end of surgery (maximum of 24 hours)
Change in the number of endovascular devices used
Demonstrate a change in the number of implantable devices used during the endovascular procedure
Measured: From beginning to end of surgery (maximum of 24 hours)
Change in the number of wasted implantable devices
Demonstrate a change in the number of devices opened but not implanted or implanted but removed during the endovascular procedure. An opened device cannot be reused.
Measured: From beginning to end of surgery (maximum of 24 hours)
Change in the amount of imaging performed during the endovascular procedure
Change in the number of angiography and computed tomography imaging series performed during and immediately after deployment
Measured: From beginning to end of surgery (maximum of 24 hours)
Change in radiation exposure due to imaging
Demonstrate a change in radiation exposure (in mGy)
Measured: From beginning to end of surgery (maximum of 24 hours)
Change in duration of hospital stay
Demonstrate a modification of the duration of hospital stay (in days) from entering the hospital to exiting the hospital.
Measured: From entering the hospital to exiting the hospital (maximum of 1 month)
Change in the number of intensive care unit transfers/stays
Demonstrate a change in the number of intensive care unit transfers/stays after the surgery
Measured: From the surgery to the end of the follow-up at 6 months
Description of decreased healthcare costs linked to the use of Sim&Size
Qualitative and quantitative analysis of hospital resources saved through the use of Sim\&Size
Measured: From enrollment to the end of follow-up at 6 months
Cost/consequence analysis of the use of Sim&Size
Carry out a cost/consequences analysis to compare the difference in costs observed in the main criterion with the multiple clinical consequences for the patient.
Measured: From enrollment to the end of follow-up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start10 Apr 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 576 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sim&Cure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07433075
- Sponsor's protocol ID
- 2025-A02544-45
- Acronym
- ESSNAI
- Status last verified
- May 2026
- First submitted
- 6 Feb 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cagnazzo F, Marnat G, Ferreira I, Daube P, Derraz I, Dargazanli C, Lefevre PH, Gascou G, Riquelme C, Morganti R, Berge J, Gariel F, Barreau X, Costalat V. Comparison of Woven EndoBridge device sizing with conventional measurements and virtual simulation using the Sim&Size software: a multicenter experience. J Neurointerv Surg. 2021 Oct;13(10):924-929. doi: 10.1136/neurintsurg-2020-017060. Epub 2020 Dec 23.
PubMed 33361275Piergallini L, Cagnazzo F, Conte G, Dargazanli C, Derraz I, Lefevre PH, Gascou G, Mantilla D, Riquelme C, Bonafe A, Costalat V. Virtual simulation with Sim&Size software for Pipeline Flex Embolization: evaluation of the technical and clinical impact. J Neurointerv Surg. 2020 Oct;12(10):968-973. doi: 10.1136/neurintsurg-2020-015813. Epub 2020 Feb 28.
PubMed 32111727
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Clinical and Economic Impact of Sim&Size, a Simulation Software for Implantable Devices Used in the Treatment of Intracranial Aneurysms: A Prospective Multicenter Study.
- ClinicalTrials.gov ID
- NCT07433075
- Acronym / sponsor ID
- ESSNAI / 2025-A02544-45
- Conditions
- Unruptured Intracranial Aneurysm
- Keywords
- endovascular, 3D simulation, healthcare costs, intracranial aneurysm, software
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 576 participants (estimated)
- Lead sponsor
- Sim&CureIndustry (pharma, biotech, devices)
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 25 Feb 2026 (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.
In recent years, endovascular treatment of intracranial aneurysms has seen remarkable growth, now surpassing traditional surgical approaches in terms of frequency of use. However, this transition to endovascular methods is not without its challenges. This type of procedure requires careful selection of the device to be implanted, a decision that is still based on manual two-dimensional measurements. This method is questionable, as it does not always take into account the complexity and specificities of certain aneurysms, where three-dimensional geometry can play a crucial role. As a result, these procedures carry significant risks, such as the need for additional maneuvers to remove or reposition devices, or even deploy another support device, which potentially increases the risk of perioperative complications, the duration of surgery, and the amount of radiation required for imaging. Beyond the impact on the patient, these complications also result in additional costs for the healthcare system, expenses that could likely be avoided if more precise and appropriate tools were used from the outset of the procedure. In this context, optimizing the choice of endovascular devices could have both clinical and economic impacts. Innovative technology such as Sim\&Size, which supports healthcare professionals in their therapeutic decisions and choice of the appropriate endovascular device, should therefore improve the effectiveness and efficiency of endovascular treatments.
Sim\&Size is a Software as a Medical Device (SaMD) intended to provide a 3D view of the final placement of neurovascular implantable medical devices of the following types: flow diverters, intrasaccular devices, stent devices, and coils. It uses an actual image of the patient produced by 3D rotational angiography. It offers physicians the possibility of simulating the deployment of implantable medical devices in the artery to be treated and predicts the final placement and the extent of apposition of the implant. Sim\&Size has CE marking and FDA clearance.
This study is a prospective, randomized, multicenter study whose main objective is to show that the use of Sim\&Size during the standard endovascular procedure, compared with a standard endovascular procedure without Sim\&Size, reduces both the actual costs of the hospital stay and the rate of perioperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual planning | Active comparator | Other: Manual planning of endovascular procedureInvestigator will use manual two-dimensional measurements to assess which neurovascular implantable medical device to use to treat the intracranial aneurysm. |
| Sim&Size planning | Experimental | Other: 3D simulation of placement of neurovascular implantable medical deviceInvestigator will use Sim\&Size software, which allows for three dimensional representation of the aneurysm and for simulation of the placement of different types of devices, to support the choice of the neurovascular implantable medical device used to treat the intracranial aneurysm. |
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 aged ≥18 years planned to be treated endovascularly for unruptured intracranial aneurysms.
- Planned implantable device models is available in the Sim\&Size simulation database and used following their approved indications.
- Affiliated with the French social security system.
- Signed the information and consent form
Key exclusion criteria (10 listed)
- Patients scheduled to undergo endovascular treatment with stents only
- Patients presenting for treatment of a ruptured aneurysm
- Patients who have already been treated in the planned deployment area and whose previous treatment presents a potential contact with the new implant.
- Giant intracranial aneurysm resulting in poor-quality reconstruction in the potential deployment area of the implant during 3DRA acquisition
- Presence of artifacts on the 3DRA in the potential deployment area of the implant
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 |
|---|---|---|
| 3D simulation of placement of neurovascular implantable medical deviceUsing the Sim\&Size software to obtain a 3D view of the final placement of neurovascular implantable medical devices of the following types: flow diverters, intrasaccular devices, stent devices, and coils, using an actual image of the patient produced by 3D rotational angiography. Used in the treatment of intracranial aneurysm. | Other | Sim&Size planning |
| Manual planning of endovascular procedureManual planning of endovascular procedure using 2D images for placement of implantable medical devices for treatment of intracranial aneurysm. | Other | Manual planning |
Primary outcome
Impact of Sim&Size use during endovascular procedure on healthcare costs
Time frame: From enrollment to the end of follow-up at 6 months
The main objective is to compare the use of Sim\&Size during a standard endovascular procedure versus manual planning in modifying the healthcare costs of the hospital stay. This objective will be demonstrated through the use of the following criteria: -Difference in average direct hospital costs between the two groups. The two primary outcomes measures will be analyzed in a sequential hierarchical manner
Impact of Sim&Size use during endovascular procedure on perioperative complications
Time frame: From enrollment to the end of follow-up at 6 months
The main objective is to compare the use of Sim\&Size during a standard endovascular procedure versus manual planning in modifying the rate of perioperative complications. This objective will be demonstrated through the use of the following criteria: Difference in the rate of perioperative complications. The two primary outcomes measures will be analyzed in a sequential hierarchical manner
13 secondary outcomes
Demonstrate a change in average hospital costs by type of endovascular device used
Time frame: From enrollment to end of follow-up at 6 months
Demonstrate a change in rate of perioperative complications by type of endovascular device used
Time frame: From surgery to the end of follow-up (6 months)
Change in the rate of aneurysm(s) recurrence
Time frame: At 6 months post surgery
Change in operating time
Time frame: From beginning to end of surgery (maximum of 24 hours)
Change of device deployment time
Time frame: From beginning to end of surgery (maximum of 24 hours)
Change in the number of endovascular devices used
Time frame: From beginning to end of surgery (maximum of 24 hours)
Change in the number of wasted implantable devices
Time frame: From beginning to end of surgery (maximum of 24 hours)
Change in the amount of imaging performed during the endovascular procedure
Time frame: From beginning to end of surgery (maximum of 24 hours)
Change in radiation exposure due to imaging
Time frame: From beginning to end of surgery (maximum of 24 hours)
Change in duration of hospital stay
Time frame: From entering the hospital to exiting the hospital (maximum of 1 month)
Change in the number of intensive care unit transfers/stays
Time frame: From the surgery to the end of the follow-up at 6 months
Description of decreased healthcare costs linked to the use of Sim&Size
Time frame: From enrollment to the end of follow-up at 6 months
Cost/consequence analysis of the use of Sim&Size
Time frame: From enrollment to the end of follow-up at 6 months
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 13 May 2026.
- Background: PubMed 33361275Cagnazzo F, Marnat G, Ferreira I, Daube P, Derraz I, Dargazanli C, Lefevre PH, Gascou G, Riquelme C, Morganti R, Berge J, Gariel F, Barreau X, Costalat V. Comparison of Woven EndoBridge device sizing with conventional measurements and virtual simulation using the Sim&Size software: a multicenter experience. J Neurointerv Surg. 2021 Oct;13(10):924-929. doi: 10.1136/neurintsurg-2020-017060. Epub 2020 Dec 23.
- Background: PubMed 32111727Piergallini L, Cagnazzo F, Conte G, Dargazanli C, Derraz I, Lefevre PH, Gascou G, Mantilla D, Riquelme C, Bonafe A, Costalat V. Virtual simulation with Sim&Size software for Pipeline Flex Embolization: evaluation of the technical and clinical impact. J Neurointerv Surg. 2020 Oct;12(10):968-973. doi: 10.1136/neurintsurg-2020-015813. Epub 2020 Feb 28.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D simulation of placement of neurovascular implantable medical device and Manual planning of endovascular procedure in people with Unruptured Intracranial Aneurysm, run by Sim&Cure at 6 sites 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 10 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 6 sites 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 Amandine RENE (+33783477287, a.rene@sim-and-cure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of Sim&Size use during endovascular procedure on healthcare costs (time frame: From enrollment to the end of follow-up at 6 months). The study lists 2 primary outcomes in all. 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 NCT07433075, which also lists 2 linked publications.
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.