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

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Vasospasm
• Intervention / Treatment: Device: NeVa VS

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113
      • RIA Neurovascular Clinic
  • Florida
    • Jacksonville, Florida, United States, 32207
      • Baptist Health System
  • Georgia
    • Marietta, Georgia, United States, 30062
      • WellStar Health System
  • New York
    • Buffalo, New York, United States, 14204
      • University of Buffalo
    • Manhasset, New York, United States, 11030
      • North Shore University Hospital - Northwell
    • New York, New York, United States, 10029
      • Mount Sinai Health System
    • Stony Brook, New York, United States, 11794
      • SUNY Stony Brook University
  • Tennessee
    • Knoxville, Tennessee, United States, 37916
      • Fort Sanders Regional Med Center
  • Texas
    • El Paso, Texas, United States, 79905
      • TTUHSC El Paso
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; NeVa VS	Device: NeVa VS; mechanical dilatation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Vesalio

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2018
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: July 26, 2018
• First Posted (Actual): August 2, 2018

Study Record Updates

• Last Update Posted (Estimate): January 2, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vasospasm, Intracranial
• Other Study ID Numbers: VS-002 / D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes