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

This is an interventional treatment trial for Cerebral Vasospasm Read More

Inclusion Criteria

• Age ≥ 18 years.
• Subarachnoid hemorrhage secondary to ruptured aneurysm.
• Ruptured aneurysm secured with surgical clipping or endovascular intervention.
• Digital subtraction angiography (DSA) or CT angiography at the time of aSAH clinical presentation or aSAH intervention with well-visualized intra-cerebral vessels is available for review.
• Vasospasm in one or more of the following: the internal carotid artery (ICA), basilar, middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral artery (PCA) territory on transcranial Doppler (TCD), and/or CT angiography, and/or clinical signs of symptomatic vasospasm (change in level of consciousness, focal neurological deficit) confirmed by > 50% narrowing in these territories on DSA.
• Vasospasm despite maximized medical management defined as oral Nimodipine (unless contraindicated), systemic hypertension with SBP greater than 130 mmHg and euvolemia.
• Target vessel pre-vasospasm diameter ≥ 2 mm and ≤ 4.0 mm.
• Subject or legal representative is able and willing to give informed consent.

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.