RecruitingNCT06893588
Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts
Prospective, Open-Label, Multi-Center ProceDural Data CollectIon Case Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (The DILATE Registry)
Sponsor
Vesalio
Enrollment
200 participants
Start Date
Apr 14, 2025
Study Type
OBSERVATIONAL
Conditions
Summary
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
Min Age: 22 Years
Inclusion Criteria4
- 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
Exclusion Criteria1
- None
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Interventions
DEVICENEVA VS
cerebral artery dilation device
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT06893588
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