Remotely controlled deflectable guidewire navigation for treating unruptured cerebral 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

The study compares the SmartGUIDE remotely controlled deflectable guidewire with standard commercially available guidewires during neurovascular procedures for unruptured cerebral aneurysms. Adults with aneurysms amenable to transcatheter treatment who provide informed consent will undergo procedures using either SmartGUIDE or a standard guidewire, with procedural navigation metrics and safety events recorded. Primary outcomes focus on navigation success and device-related complications observed during the intervention. The trial is conducted at CHU Limoges and captures intra-procedural performance and immediate safety endpoints.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* \>18 years of age
* Informed consent signed by the patient
* Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

Exclusion Criteria:

* Pregnancy or lactation
* Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
* Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
* Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
* Uncontrolled serum electrolyte imbalance
* Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
* Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
* Known hypersensitivity to Nickel
* Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints

Where it's running

• Centre Hospitalier Universitaire - CHU Limoges
  Limoges, France Recruiting

Study contacts

• Principal investigator: Prof. Dr. Aymeric Rouchaud — Centre Hospitalier Universitaire - CHU Limoges
• Study coordinator: Guillaume Petit-Pierre, PhD
• Email: clinical@artiria-medical.com
• Phone: +41215220844

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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.