Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age22+
SponsorVesalio
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥22
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)
Vessel dilation procedure was performed with the NeVa VS
Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure
Disqualifiers
None
Trial population
subjects with cerebral vasospasm
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
NEVA VS
Devicecerebral artery dilation device
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
Improvement in target vessel diameter following NeVa VS use
Time frame
Up to 1 hour post procedure Source ClinicalTrials.gov