Real-time Deflectable Guidewire in Neuro-interventions Study

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 Overview

• Status: Terminated
• Conditions: Unruptured Cerebral Aneurysm
• Intervention / Treatment: Device: SmartGUIDE (deflectable guidewire)

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland
    • Geneva University Hospital - HUG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: SmartGUIDE (deflectable guidewire)

Device: SmartGUIDE (deflectable guidewire); SmartGUIDE is a deflectable guidewire for use in interventional procedures in the neurovasculature and the peripheral vasculature. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. The device is a steerable guidewire with a deflectable tip. This allows adjusting the shape of the tip, dynamically, while the physician navigates the device in the patient's arterial and venous circulatory system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance	Intra-procedural technical success defined as successful navigation of device to the vascular target vessel without need for shaping, removal or exchange.	During index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability	Usability data (pushability, trackability, navigatability, shape retention, support, and proximal access complexity) collected through questionnaire completed by the physician. Measured through a Likert scale from 1-5.	During index procedure
Procedural times	Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).	During index procedure
Safety - intra- and postprocedural	Adverse events, measured by the occurrence of adverse events	During index procedure and up to 48 hours post procedure
Device Deficiencies	Intraprocedural device deficiencies, measured by the occurrence of device deficiencies/malfunctions	During index procedure

Collaborators and Investigators

• Sponsor: Artiria Medical
• Investigators: Principal Investigator: Paolo Machi, Professor, Geneva University Hospital - HUG

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2023
• Primary Completion (Actual): March 10, 2026
• Study Completion (Actual): March 10, 2026

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): October 3, 2022

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: 2022-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No