Last updated: February 28, 2024
Sponsor: Artiria Medical
Overall Status: Active - Recruiting
Phase
N/A
Condition
Aneurysm
Treatment
Standard of care guidewire (different models may be used)
Deflectable guidewire
Clinical Study ID
NCT05564325
2022-01
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
Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Standard of care guidewire (different models may be used)
Phase:
Study Start date:
April 19, 2023
Estimated Completion Date:
March 31, 2024
Connect with a study center
Geneva University Hospital - HUG
Geneva,
SwitzerlandActive - Recruiting
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