Real-time Deflectable Guidewire in Neuro-interventions Study

Not Applicable

Recruiting

• Conditions: Unruptured Cerebral Aneurysm
• Interventions: Device: Standard of care guidewire (different models may be used); Device: Deflectable guidewire

• Registration Number: NCT05564325
• Lead Sponsor: Artiria Medical

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-09-29
• Study First Posted: 2022-10-03
• Study Start: 2023-04-19
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care guidewire	Standard of care guidewire (different models may be used)	-
Deflectable guidewire	Deflectable guidewire	-

Primary Outcome Measures

Name	Time	Method
Performance	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 Outcome Measures

Name	Time	Method
Procedural times	During index procedure	Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).
Safety - intra- and postprocedural	During index procedure and up to 48 hours post procedure	Adverse events, measured by the occurrence of adverse events
Device Deficiencies	During index procedure	Intraprocedural device deficiencies, measured by the occurrence of device deficiencies/malfunctions
Usability	During index procedure	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.

Trial Locations

Locations (2)

Centre Hospitalier Universitaire Vaudois (CHUV); 🇨🇭 Lausanne, Switzerland

Geneva University Hospital - HUG; 🇨🇭 Geneva, Switzerland