Using a new guidewire for treating unruptured cerebral aneurysms
Real-time Deflectable Guidewire in Neuro-interventions Study
This study is testing a new guidewire to see if it can make treating unruptured cerebral aneurysms safer and more effective compared to the standard guidewires currently used.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Artiria Medical Industry-sponsored |
| Locations | 2 sites (Geneva and 1 other locations) |
| Trial ID | NCT05564325 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of the SmartGUIDE deflectable guidewire in neuro-interventions for unruptured cerebral aneurysms. It compares the performance of this innovative guidewire against standard guidewires currently used in clinical practice. Participants will undergo procedures using either the SmartGUIDE or standard guidewires to determine which provides better outcomes. The study aims to enhance the precision and safety of neurovascular interventions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a confirmed unruptured cerebral aneurysm that can be treated via a transcatheter approach.
Not a fit: Patients with conditions such as vascular fragility disorders or those currently enrolled in conflicting studies may not benefit from this trial.
Why it matters
Potential benefit: If successful, this could lead to improved treatment outcomes and safety for patients with unruptured cerebral aneurysms.
How similar studies have performed: While the use of guidewires in neuro-interventions is established, the specific application of the SmartGUIDE is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \>18 years of age * Informed consent signed by 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 this trial is running
Geneva and 1 other locations
- Geneva University Hospital - HUG — Geneva, Switzerland (Recruiting)
- Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Switzerland (Not_yet_recruiting)
Study contacts
- Principal investigator: Paolo Machi, Professor — Geneva University Hospital - HUG
- Study coordinator: Guillaume Petit-Pierre, PhD
- Email: info@artiria-medical.com
- Phone: +41 21 522 08 44
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.