Status:
NOT_YET_RECRUITING
Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts
Lead Sponsor:
Vesalio
Conditions:
Cerebral Vasospasm
Aneurysmal Subarachnoid Hemorrhage (aSAH)
Eligibility:
All Genders
22+ years
Brief 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 subarachno...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
April 14 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 15 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06893588
Start Date
April 14 2025
End Date
March 15 2027
Last Update
March 25 2025
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