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. (ESSNAI)

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 Overview

• Status: Recruiting
• Conditions: Unruptured Intracranial Aneurysm
• Intervention / Treatment: Other: Manual planning of endovascular procedure; Other: 3D simulation of placement of neurovascular implantable medical device

• Study Type: Interventional
• Enrollment (Estimated): 576
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandine RENE; Phone Number: +33783477287; Email: a.rene@sim-and-cure.com

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • CHU d'Angers
    • Principal Investigator: Jean-Baptiste Girot, Dr
  • Bordeaux, France, 33000
    • Recruiting
    • CHU de Bordeaux
    • Principal Investigator: Gaultier Marnat, Dr
  • Le Kremlin-Bicêtre, France, 94270
    • Recruiting
    • Hôpital Bicêtre AP-HP
    • Principal Investigator: Laurent Spelle, Dr
  • Marseille, France, 13005
    • Not yet recruiting
    • Hôpital de la Timone
    • Principal Investigator: Jean-François Hak, Dr
  • Paris, France, 75019
    • Not yet recruiting
    • Fondation Rothschild
    • Principal Investigator: Raphaël Blanc, Dr
  • Reims, France, 51092
    • Not yet recruiting
    • CHU de Reims
    • Principal Investigator: Laurent Pierrot, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Manual planning; Investigator will use manual two-dimensional measurements to assess which neurovascular implantable medical device to use to treat the intracranial aneurysm.	Other: Manual planning of endovascular procedure; Manual planning of endovascular procedure using 2D images for placement of implantable medical devices for treatment of intracranial aneurysm.
Experimental: Sim&Size planning; 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.	Other: 3D simulation of placement of neurovascular implantable medical device; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	From enrollment to the end of follow-up at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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	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.	At 6 months post surgery
Change in operating time	Demonstrate a change in operating time during the endovascular procedure (in minutes)	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)	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	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.	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	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)	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.	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	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	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.	From enrollment to the end of follow-up at 6 months

Collaborators and Investigators

• Sponsor: Sim&Cure

Publications and helpful links

General 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.
• Piergallini 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: endovascular; intracranial aneurysm; software; healthcare costs; 3D simulation
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 2025-A02544-45

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No