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

Cerebral Vasospasm Clinical Trial

Official title:

The Vesalio Neva VS for the Treatment of Symptomatic Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage (aSAH) (The VITAL Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611790
• Other study ID #: VS-002 / D
• Status: Completed
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: May 31, 2021

Study information

• Verified date: December 2022
• Source: Vesalio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Vasospasm
• Vasospasm, Intracranial

Intervention

Device:
• NeVa VS
mechanical dilatation

Locations

Country	Name	City	State
United States	University of Buffalo	Buffalo	New York
United States	TTUHSC El Paso	El Paso	Texas
United States	RIA Neurovascular Clinic	Englewood	Colorado
United States	Houston Methodist Hospital	Houston	Texas
United States	Baptist Health System	Jacksonville	Florida
United States	Fort Sanders Regional Med Center	Knoxville	Tennessee
United States	North Shore University Hospital - Northwell	Manhasset	New York
United States	Wellstar Health System	Marietta	Georgia
United States	Mount Sinai Health System	New York	New York
United States	SUNY Stony Brook University	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
Vesalio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Success	defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory	within 30 minutes of completion of procedure