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Clinical Trials/NCT05564325
NCT05564325TerminatedNot Applicable

Real-time Deflectable Guidewire in Neuro-interventions Study

Artiria Medical2 sites in 1 country5 target enrollmentStarted: April 19, 2023Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
5
Locations
2
Primary Endpoint
Performance
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

SmartGUIDE (deflectable guidewire)

Experimental

Intervention: SmartGUIDE (deflectable guidewire) (Device)

Outcomes

Primary Outcomes

Performance

Time Frame: During index procedure

Intra-procedural technical success defined as successful navigation of device to the vascular target vessel without need for shaping, removal or exchange.

Secondary Outcomes

  • Procedural times(During index procedure)
  • Safety - intra- and postprocedural(During index procedure and up to 48 hours post procedure)
  • Device Deficiencies(During index procedure)
  • Usability(During index procedure)

Investigators

Sponsor
Artiria Medical
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (2)

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