Comparison of Woven EndoBridge device sizing with conventional measurements and virtual simulation using the Sim&Size software: a multicenter experience.
Federico Cagnazzo, Gaultier Marnat, Ivan Ferreira...
https://pubmed.ncbi.nlm.nih.gov/33361275Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07433075
Assessment of the Clinical and Economic Impact of Sim&Size Simulation Software for Implantable Devices in Treating Unruptured Intracranial Aneurysms
Led by Sim&Cure · Updated on 2026-05-13
576
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 software's impact on care efficiency and effectiveness.
CONDITIONS
Brief Title
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.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older planned for endovascular treatment of unruptured intracranial aneurysms
- Planned implantable device models must be available in the Sim&Size simulation database and used according to approved indications
- Affiliated with the French social security system
- Signed the information and consent form
You will not qualify if you...
- Patients scheduled for endovascular treatment using stents only
- Patients with ruptured aneurysms
- Patients previously treated in the planned deployment area with potential contact between old and new implants
- Giant intracranial aneurysms causing poor-quality 3D reconstruction in the deployment area
- Presence of artifacts on 3D rotational angiography in the deployment area
- Patients with multiple aneurysms requiring separate individual treatment strategies during one procedure
- Patients previously pre-planned with Sim&Cure software before randomization
- Pregnant or breastfeeding women
- Patients under guardianship or conservatorship
- Emergency situations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 1 month
Participants undergo endovascular treatment for unruptured intracranial aneurysms using either manual planning or Sim&Size 3D simulation software to guide device placement.
1 surgery and hospital stay visit
Follow-up
Duration - 6 months
Participants are monitored for perioperative complications, aneurysm recurrence, and healthcare costs after treatment.
Regular visits during the 6 months follow-up
Trial Site Locations
Total: 6 locations
1
CHU d'Angers
Angers, France, 49100
Actively Recruiting
2
CHU de Bordeaux
Bordeaux, France, 33000
Actively Recruiting
3
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
4
Hôpital de La Timone
Marseille, France, 13005
Not Yet Recruiting
5
Fondation Rothschild
Paris, France, 75019
Not Yet Recruiting
6
CHU de Reims
Reims, France, 51092
Not Yet Recruiting
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Research Team
A
Amandine RENE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Virtual simulation with Sim&Size software for Pipeline Flex Embolization: evaluation of the technical and clinical impact.
Lorenzo Piergallini, Federico Cagnazzo, Giorgio Conte...
https://pubmed.ncbi.nlm.nih.gov/32111727