Recruiting NCT06972953
NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SmartGUIDE (deflectable guidewire), Any standard of care guidewire.
- Who it may be relevant to
- Registry conditions: Unruptured Cerebral Aneurysm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The aim of the study is to confirm the safe and successful use of the SmartGUIDE guidewire, when used in neuro interventions. The performance of the SmartGUIDE guidewire in terms of safe and successful navigation within the neurovasculature will be compared to standard of care guidewire on the market.
Interventions
- Device SmartGUIDE (deflectable guidewire)
SmartGUIDE is 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. - Device Any standard of care guidewire
The control device is any standard of care guidewire as per hospital routine indicated for neuro-interventional procedures.
Primary outcome measures
- Performance [Time frame: During index procedure]
Secondary outcome measures (4)
- Usability [Time frame: During index procedure]
- Procedural times [Time frame: During index procedure]
- Intra-procedural adverse events [Time frame: During index procedure and up to 48 hours post procedure]
- Intra-procedural device deficiencies [Time frame: During index procedure]
Eligibility criteria
Inclusion criteria
- >18 years of age
- Informed consent signed by the 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Centre Hospitalier Universitaire - CHU Limoges — Limoges
Identifiers
NCT: NCT06972953 · FR 2024