Real-time Deflectable Guidewire in Neuro-interventions Study

NCT05564325 | Terminated DMC

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Unruptured Cerebral Aneurysm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Usability

  During index procedure

• Procedural times

  During index procedure

• Safety - intra- and postprocedural

  During index procedure and up to 48 hours post procedure

• Device Deficiencies

  During index procedure

Study Arms (1)

SmartGUIDE (deflectable guidewire)

EXPERIMENTAL

Device: SmartGUIDE (deflectable guidewire)

Interventions

SmartGUIDE (deflectable guidewire) DEVICE

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.

SmartGUIDE (deflectable guidewire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>18 years of age
• Informed consent signed by patient
• Confirmed cerebral unruptured aneurysm treatable via transcatheter approach

You may not qualify if:

• 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

Sponsors & Collaborators

• Artiria Medical: lead

Study Sites (1)

Geneva University Hospital - HUG

Geneva, Switzerland

Location

Study Officials

• Paolo Machi, Professor

  Geneva University Hospital - HUG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 3, 2022
• Study Start: April 19, 2023
• Primary Completion: March 10, 2026
• Study Completion: March 10, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)