Vesalio NeVa VS for Symptomatic Cerebral Vasospasm Following aSAH (The VITAL Study)
- Conditions
- Cerebral Vasospasm
- Interventions
- Device: NeVa VS
- Registration Number
- NCT03611790
- Lead Sponsor
- Vesalio
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention NeVa VS NeVa VS
- Primary Outcome Measures
Name Time Method Procedural Success within 30 minutes of completion of procedure defined as 50% or greater vessel caliber on DSA compared to baseline, as determined by the core laboratory
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
RIA Neurovascular Clinic
🇺🇸Englewood, Colorado, United States
Baptist Health System
🇺🇸Jacksonville, Florida, United States
Wellstar Health System
🇺🇸Marietta, Georgia, United States
North Shore University Hospital - Northwell
🇺🇸Manhasset, New York, United States
University of Buffalo
🇺🇸Buffalo, 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