Testing Silk Vista Baby (SVB) Flow Diverter for intracranial aneurysm

Exclusion

• −Has a medical contraindication to study or procedure-related antiplatelet/anticoagulation medications (e.g., aspirin, clopidogrel/Plavix, ticagrelor, Prasugrel, Gp IIb/IIIa inhibitors, heparin, etc.), local or general anesthesia, or life-threatening allergy to contrast dye
• −Has a known severe allergy to nickel, titanium or platinum
• −Target aneurysm is unsuitable for flow diverter treatment
• −Subject requires more than one flow diverter for target aneurysm treatment
• −Has vessel characteristics, such as severe tortuosity, stenosis, atherosclerotic disease, or morphology that would preclude safe endovascular access to the target aneurysm necessary for treatment with the study device
• −Received previous treatment of the target aneurysm or parent artery where it would interfere with the placement or proper apposition of the device
• −Modified Rankin Score (mRS) assessment is ≥ 3 at screeningScreeningThe checks done before joining, to see whether a study fits.Read more → or pre-procedure mRS could not be assessed
• −The health of the participant or the validity of the study outcomes (e.g., high risk of neurologic events, worsening of clinical condition in the last 30 days) may be compromised by the participant's enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →
• −Subarachnoid hemorrhage occurred within 30 days prior to enrollment
• −Intracranial parenchymal hemorrhage occurred within 60 days prior to enrollment
• −Has more than one IA that requires treatment within 120 days of treatment date
• −Received previous intracranial implant associated with the symptomatic or vascular distribution within the past 12 weeks prior to treatment date
• −Requires adjunctive coiling during SVB procedure
• −Chronic anticoagulation therapy is ongoing or known coagulopathy exists
• −Life expectancy is less than 5 years due to other illness or condition (in addition to an intracranial aneurysm)
• −Unable to complete study follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → due to dementia or psychiatric disorder, substance abuse, or history of noncompliance with medical advice
• −Participation in any other investigational study which can influence collection of valid data under this study
• −Women who are pregnant or nursing at the time of enrollment or women who wish to become pregnant during the length of study participation
• −Major surgery (including previous intracranial implant) occurred within previous 30 days or is planned in the next 120 days after treatment date
• −Has other known serious concurrent medical conditions such as active bacterial infection, heart disease (including atrial fibrillation, pacemaker, recent myocardial infarction \[\< 12 weeks\], symptomatic congestive heart failure, or carotid stenosis), kidney failure (e.g., \>2.0mg/dl serum creatinine) or any other non-neurological disease-related acute life threatening illness to be treated in this trial, pulmonary disease, uncontrolled diabetes, progressive neurologic disorders, cancer requiring active treatment (e.g., chemotherapy, etc.) or on palliative care, vasculitis, high risk of ischemic stroke or recent stroke (within 30 days)
• −Presence of intracranial mass (tumor, except meningioma that doesn't require surgery for 1 year) or non-treated arteriovenous malformation (AVM) in the territory of the target aneurysm