Clinical trial NCT03611790: Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)
Official title: The Vesalio Neva VS for the Treatment of Symptomatic Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage (aSAH) (The VITAL Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Vasospasm
Lead sponsor: Vesalio
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Procedural Success
timeFrame: within 30 minutes of completion of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Englewood
country: United States
facility: RIA Neurovascular Clinic
state: Colorado
city: Jacksonville
country: United States
facility: Baptist Health System
state: Florida
city: Marietta
country: United States
facility: Wellstar Health System
state: Georgia
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Manhasset
country: United States
facility: North Shore University Hospital - Northwell
state: New York
city: New York
country: United States
facility: Mount Sinai Health System
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook University
state: New York
city: Knoxville
country: United States
facility: Fort Sanders Regional Med Center
state: Tennessee
city: El Paso
country: United States
facility: TTUHSC El Paso
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
References: