search
Back to results

Real-time Deflectable Guidewire in Neuro-interventions Study

Primary Purpose

Unruptured Cerebral Aneurysm

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Deflectable guidewire
Standard of care guidewire (different models may be used)
Sponsored by
Artiria Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Unruptured Cerebral Aneurysm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Geneva University Hospital - HUGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Deflectable guidewire

Standard of care guidewire

Arm Description

Outcomes

Primary Outcome Measures

Performance
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

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.
Procedural times
Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).
Safety - intra- and postprocedural
Adverse events, measured by the occurrence of adverse events
Device Deficiencies
Intraprocedural device deficiencies, measured by the occurrence of adverse events

Full Information

First Posted
September 29, 2022
Last Updated
June 7, 2023
Sponsor
Artiria Medical
search

1. Study Identification

Unique Protocol Identification Number
NCT05564325
Brief Title
Real-time Deflectable Guidewire in Neuro-interventions Study
Official Title
Real-time Deflectable Guidewire in Neuro-interventions Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 19, 2023 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Artiria Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unruptured Cerebral Aneurysm

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Deflectable guidewire
Arm Type
Experimental
Arm Title
Standard of care guidewire
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Deflectable guidewire
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard of care guidewire (different models may be used)
Intervention Description
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
Primary Outcome Measure Information:
Title
Performance
Description
Intra-procedural technical success defined as successful navigation of device to the vascular target vessel without need for shaping, removal or exchange.
Time Frame
During index procedure
Secondary Outcome Measure Information:
Title
Usability
Description
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.
Time Frame
During index procedure
Title
Procedural times
Description
Procedural times (duration of tip reshaping, duration of access to target, duration of fluoroscopic exposition).
Time Frame
During index procedure
Title
Safety - intra- and postprocedural
Description
Adverse events, measured by the occurrence of adverse events
Time Frame
During index procedure and up to 48 hours post procedure
Title
Device Deficiencies
Description
Intraprocedural device deficiencies, measured by the occurrence of adverse events
Time Frame
During index procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Petit-Pierre, PhD
Phone
+41 21 522 08 44
Email
info@artiria-medical.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Machi, Professor
Organizational Affiliation
Geneva University Hospital - HUG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geneva University Hospital - HUG
City
Geneva
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Machi, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Real-time Deflectable Guidewire in Neuro-interventions Study

We'll reach out to this number within 24 hrs