Real-time Deflectable Guidewire in Neuro-interventions Study

Launched by ARTIRIA MEDICAL · Sep 29, 2022

Keywords

ClinConnect Summary

The Real-time Deflectable Guidewire in Neuro-interventions Study is exploring a new tool called the SmartGUIDE guidewire, which is used during procedures to treat unruptured cerebral aneurysms. The goal of the study is to see if this guidewire can be used safely and effectively compared to the standard guidewires currently available. If you or someone you know has an unruptured cerebral aneurysm and is between the ages of 18 and 74, you might be eligible to participate in this trial, provided you meet certain health criteria.

Participants in this study will sign an informed consent form, which means they understand what the study involves. Throughout the trial, they will receive care and monitoring to ensure their safety while using the SmartGUIDE guidewire. However, some individuals may not be eligible due to specific health conditions, such as pregnancy, certain heart issues, or allergies. This study is currently recruiting participants, and it could be a valuable opportunity for those seeking treatment for their condition.

Gender

ALL

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