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.

NCT07433075 | Not Yet Recruiting

• 1 other identifier: 2025-A02544-45
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 6

Brief 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. 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

Keywords

endovascular; 3D simulation; healthcare costs; intracranial aneurysm; software

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Demonstrate a change in average hospital costs by type of endovascular device used

  From enrollment to end of follow-up at 6 months

• 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

  At 6 months post surgery

• Change in operating time

  From beginning to end of surgery (maximum of 24 hours)

• Change of device deployment time

  From beginning to end of surgery (maximum of 24 hours)

Study Arms (2)

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.

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.

Other: 3D simulation of placement of neurovascular implantable medical device

Interventions

3D simulation of placement of neurovascular implantable medical device OTHER

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.

Sim&Size planning

Manual planning of endovascular procedure OTHER

Manual planning of endovascular procedure using 2D images for placement of implantable medical devices for treatment of intracranial aneurysm.

Manual planning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sim&Cure: lead

Study Sites (6)

CHU d'Angers

Angers, 49100, France

Location

CHU de Bordeaux

Bordeaux, 33000, France

Location

Hôpital Bicêtre AP-HP

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital de La Timone

Marseille, 13005, France

Location

Fondation Rothschild

Paris, 75019, France

Location

CHU de Reims

Reims, 51092, France

Location

Related Publications (2)

• 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.

  PMID: 33361275 BACKGROUND

• 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.

  PMID: 32111727 BACKGROUND

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Amandine RENE

CONTACT

+33783477287; a.rene@sim-and-cure.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 25, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

FR (6)