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

Vesalio

Status

Completed

Conditions

Cerebral Vasospasm

Treatments

Device: NeVa VS

Study type

Interventional

Funder types

Industry

Identifiers

NCT03611790

VS-002 / D

Details and patient eligibility

About

The objective of the study is to assess the safety and probable benefit of the Neva VS device in patients presenting with symptomatic cerebral vasospasm despite maximal medical management following aSAH.

Full description

This is a prospective, open label, single-arm study. Up to 30 eligible subjects at up to 15 sites will participate in the study. Subjects will be followed up for 30 days post-intervention.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.