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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2021-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cerebral Vasospasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

NeVa VS

Group Type EXPERIMENTAL

NeVa VS

Intervention Type DEVICE

mechanical dilatation

Interventions

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NeVa VS

mechanical dilatation

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No