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
About this trial
This is an interventional other trial for Unruptured Cerebral Aneurysm
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
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
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
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Real-time Deflectable Guidewire in Neuro-interventions Study
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