Real-time Deflectable Guidewire in Neuro-interventions Study
Megadott ok: The study was prematurely terminated after the successful completion of the pilot phase and the EU CE marking was obtained, rendering the continuation no longer necessary. The study was not terminated for reasons related to participants' safety.
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
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A vizsgálat adatai
- Ki végzi
- Artiria Medical
- Azonosító
- NCT05564325
- A regiszteradat frissítve
- 2026. április 13.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: >18 years of age; Informed consent signed by patient; Confirmed cerebral unruptured aneurysm treatable via transcatheter approach.
Kizáró feltételek: Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures; Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication; Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints; Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome); Acute phase myocardial infarction or uncontrolled cardiac arrhythmia; Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy; Known hypersensitivity to Nickel; Uncontrolled serum electrolyte imbalance; Pregnancy or lactation.