Clinical and economic impact of Sim&Size 3D simulation for planning implants in unruptured intracranial aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.