Study of Sim&Size Software to Improve Treatment and Reduce Costs for Unruptured Intracranial Aneurysms Using Endovascular Devices

What this Trial Is About

Researchers are studying the use of Sim&Size, a software that provides a three-dimensional view and simulation of implantable devices for treating unruptured intracranial aneurysms. This software aims to improve the selection of endovascular devices, compared to the standard manual two-dimensional measurement methods, which may not fully capture the complex shape of aneurysms. The goal is to reduce perioperative complications and hospital costs associated with these procedures. Participants in this trial will be randomly assigned to one of two groups one where the device choice is made using traditional manual 2D measurements, and another where the Sim&Size software supports the decision by simulating device placement in 3D. The software uses images from 3D rotational angiography and is designed to predict the final placement and fit of devices such as flow diverters, intrasaccular devices, stents, and coils. The study is prospective, randomized, and conducted across multiple centers. During the study, researchers will monitor participants from enrollment through six months after treatment, assessing healthcare costs and rates of perioperative complications. Additional measurements include hospital costs by device type, recurrence of aneurysms, operating and device deployment times, number and wastage of devices used, imaging and radiation exposure during surgery, hospital stay length, and intensive care usage. The study also includes economic evaluations of the Sim&Size softwares impact on care efficiency and effectiveness.

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.