Phase
Condition
Aneurysm
Treatment
Standard of care guidewire (different models may be used)
SmartGUIDE (deflectable guidewire)
Deflectable guidewire
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
>18 years of age
Informed consent signed by patient
Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
Exclusion
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 becatheterized 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 adequatelycontrolled with pre-medication
Known hypersensitivity to Nickel
Subjects currently enrolled in another investigational device or drug study thatclinically interferes with the current study endpoints
Study Design
Connect with a study center
Geneva University Hospital - HUG
Geneva,
SwitzerlandActive - Recruiting
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, 1005
SwitzerlandSite Not Available
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