NCT07433075

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.

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Sim&Cure · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-08-01
• Completion: 2028-08-01
• First posted: 2026-02-25
• Last updated: 2026-02-25

Locations

6 sites across 1 country: France