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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
mechanical dilatation
RIA Neurovascular Clinic
Englewood, Colorado, United States
Baptist Health System
Jacksonville, Florida, United States
Wellstar Health System
Marietta, Georgia, United States
Procedural Success
defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
Time frame: within 30 minutes of completion of procedure
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University of Buffalo
Buffalo, New York, United States
North Shore University Hospital - Northwell
Manhasset, New York, United States
Mount Sinai Health System
New York, New York, United States
SUNY Stony Brook University
Stony Brook, New York, United States
Fort Sanders Regional Med Center
Knoxville, Tennessee, United States
TTUHSC El Paso
El Paso, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States