Real-time Deflectable Guidewire in Neuro-interventions Study

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

The aim of the study is to assess the safe and successful use of the SmartGUIDE guidewire in neuro interventions and to compare to standard of care guidewires on the market.

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,
    Switzerland

    Active - Recruiting

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