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.

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Impact of Sim&Size use during endovascular procedure on healthcare costs [Срок оценки: From enrollment to the end of follow-up at 6 months]
• Impact of Sim&Size use during endovascular procedure on perioperative complications [Срок оценки: From enrollment to the end of follow-up at 6 months]

Вторичные конечные точки (12)

• Demonstrate a change in average hospital costs by type of endovascular device used [Срок оценки: From enrollment to end of follow-up at 6 months]
• Demonstrate a change in rate of perioperative complications by type of endovascular device used [Срок оценки: From surgery to the end of follow-up (6 months)]
• Change in the rate of aneurysm(s) recurrence [Срок оценки: At 6 months post surgery]
• Change in operating time [Срок оценки: From beginning to end of surgery (maximum of 24 hours)]
• Change of device deployment time [Срок оценки: From beginning to end of surgery (maximum of 24 hours)]
• Change in the number of endovascular devices used [Срок оценки: From beginning to end of surgery (maximum of 24 hours)]
• Change in the number of wasted implantable devices [Срок оценки: From beginning to end of surgery (maximum of 24 hours)]
• Change in the amount of imaging performed during the endovascular procedure [Срок оценки: From beginning to end of surgery (maximum of 24 hours)]
• Change in radiation exposure due to imaging [Срок оценки: From beginning to end of surgery (maximum of 24 hours)]
• Change in duration of hospital stay [Срок оценки: From entering the hospital to exiting the hospital (maximum of 1 month)]
• Change in the number of intensive care unit transfers/stays [Срок оценки: 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 [Срок оценки: From enrollment to the end of follow-up at 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 6 центров

• CHU d'Angers — Angers
• CHU de Bordeaux — Bordeaux
• Hôpital Bicêtre AP-HP — Le Kremlin-Bicêtre
• Hôpital de La Timone — Marseille
• Fondation Rothschild — Paris
• CHU de Reims — Reims

Публикации

• 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 202 PMID 33361275
• 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

Идентификаторы

NCT: NCT07433075 · 2025-A02544-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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