Clinical and economic impact of Sim&Size 3D simulation for planning implants in unruptured intracranial aneurysms
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.
This trial will test whether using Sim&Size 3D simulation software to plan implantable devices reduces complications, procedure time, radiation exposure, and costs for adults having endovascular treatment of unruptured intracranial aneurysms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 576 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sim&Cure Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 6 sites (Angers and 5 other locations) |
| Trial ID | NCT07433075 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter interventional study comparing 3D simulation-guided device planning using the Sim&Size software with conventional manual 2D planning for endovascular treatment of unruptured intracranial aneurysms. Participating centers will use the simulation when the planned implant model is available in the Sim&Size database and will collect clinical, procedural, radiation, and cost-related outcomes. Key endpoints include need for device repositioning or additional devices, perioperative complications, procedure duration, imaging radiation dose, and economic impact. The study is being conducted at multiple French hospitals and requires patient consent and French social security affiliation.
Who should consider this trial
Good fit: Adults (≥18 years) scheduled for endovascular treatment of an unruptured intracranial aneurysm whose planned implant model is present in the Sim&Size database, who are treated at a participating French center and covered by the French social security system, and who provide informed consent.
Not a fit: Patients with ruptured aneurysms, planned stent-only procedures, prior implants in the target area, giant aneurysms or poor-quality 3D imaging, significant imaging artifacts, or complex multiple-aneurysm procedures planned in a single session are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the software could reduce intra-procedural device maneuvers, lower complication risk, shorten procedures, decrease radiation exposure, and cut healthcare costs.
How similar studies have performed: Prior observational and pilot studies of 3D simulation and virtual sizing in neurovascular and other endovascular fields have suggested improved device sizing and fewer intra-procedural adjustments, but randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
Where this trial is running
Angers and 5 other locations
- CHU d'Angers — Angers, France (Recruiting)
- CHU de Bordeaux — Bordeaux, France (Recruiting)
- Hôpital Bicêtre AP-HP — Le Kremlin-Bicêtre, France (Recruiting)
- Hôpital de La Timone — Marseille, France (Not_yet_recruiting)
- Fondation Rothschild — Paris, France (Not_yet_recruiting)
- CHU de Reims — Reims, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Amandine RENE
- Email: a.rene@sim-and-cure.com
- Phone: +33783477287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.