AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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.

RecruitingNAAges 18 Years - anyAllSim&Cure
💬

In plain words

What the trial is, and whether it could suit you

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. Be

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
💊

What it tests

  • 3D simulation of placement of neurovascular implantable medical device
  • Manual planning of endovascular procedure
📍

Where

6 sites
CHU d'Angers
Angers, France
CHU de Bordeaux
Bordeaux, France
Hôpital Bicêtre AP-HP
Le Kremlin-Bicêtre, France
Hôpital de La Timone
Marseille, France
Fondation Rothschild
Paris, France
CHU de Reims
Reims, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy