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Purpose

A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)

Conditions

Eligibility

Eligible Ages
Over 22 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥22 2. Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA) 3. Vessel dilation procedure was performed with the NeVa VS 4. Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure

Exclusion Criteria

  • None

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Case-Only
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Treatment Group
  • Device: NEVA VS
    cerebral artery dilation device

Recruiting Locations

Miami Baptist
Miami, Florida 33176
Contact:
Italo Linfante, MD
786-596-3876
italol@baptisthealth.net

Uni. of Utah
Salt Lake City, Utah 84112
Contact:
Karol Budohoski, MD
801-585-7575
karol.budohoski@hsc.utah.edu

More Details

Status
Recruiting
Sponsor
Vesalio

Study Contact

Sharon Shachar, Graduate
2486976616
sshachar@vesalio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.