Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)

Exclusion Criteria

• •The presence of an unsecured ruptured aneurysm. Note unsecured unruptured aneurysms remote to the site of treated aSAH are not an exclusionary.
• •Symptoms attributable to other causes (e.g., hydrocephalus, metabolic, infection).
• •Hunt and Hess Grade of 5
• •Large infarct on CT scan defined as ASPECTS 0-5.
• •Intracranial hemorrhage not caused by aneurysm rupture.
• •History of bleeding disorders.
• •Baseline platelets \< 30,000.
• •International normalized ratio (INR) \> 1.7.
• •Any known contraindications to mechanical dilation of vasospastic vessels including but not limited to:
• •Excessive vessel tortuosity that prevents the placement of the device
• •Evidence of rapidly improving neurological signs of stroke
• •Large territory completed cerebral infarction, edema with mass effect and intra-parenchymal hemorrhage in vascular territory to be treated, or
• •any other vascular anatomic variants or anomalies
• •Pre-existing neurological or psychiatric disease that would confound the neurological or functional evaluations, e.g. dementia with prescribed anti-cholinesterase inhibitor (e.g. Aricept).
• •History of severe allergy to contrast medium.
• •Known allergy to NeVa materials (nitinol, stainless steel).
• •Suspected or confirmed septic embolus, or bacterial endocarditis.
• •Septic shock or central nervous system (CNS) infection confirmed via cerebrospinal fluid (CSF) sampling.
• •Known current or recent use of illicit drugs or alcohol abuse.
• •Females who are pregnant or breastfeeding.
• •Any other condition that, in the opinion of the investigator, precludes an endovascular procedure or poses a significant hazard to the subject if an endovascular procedure is performed.