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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)

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

NCT ID

NCT05564325

First Posted

September 29, 2022

Last Updated

June 7, 2023

Sponsor

Artiria Medical

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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Real-time Deflectable Guidewire in Neuro-interventions Study

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