Real-time Deflectable Guidewire in Neuro-interventions Study

Unruptured Cerebral Aneurysm Clinical Trial

Official title:

Real-time Deflectable Guidewire in Neuro-interventions Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05564325
• Other study ID #: 2022-01
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2023
• Est. completion date: March 2024

Study information

• Verified date: February 2024
• Source: Artiria Medical
• Contact: Guillaume Petit-Pierre, PhD
• Phone: +41 21 522 08 44
• Email: info[@]artiria-medical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Unruptured Cerebral Aneurysm

Intervention

Device:
• Deflectable guidewire
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.
• Standard of care guidewire (different models may be used)
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.

Locations

Country	Name	City	State
Switzerland	Geneva University Hospital - HUG	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Artiria Medical

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Procedural times	Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).	During index procedure
Secondary	Safety - intra- and postprocedural	Adverse events, measured by the occurrence of adverse events	During index procedure and up to 48 hours post procedure
Secondary	Device Deficiencies	Intraprocedural device deficiencies, measured by the occurrence of adverse events	During index procedure