Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (DILATE)

Vesalio

Status: Not yet enrolling

Conditions: Aneurysmal Subarachnoid Hemorrhage (aSAH); Cerebral Vasospasm

Treatments: Device: NEVA VS

Study type: Observational

Funder types: Industry

Identifiers

NCT06893588

VS-011

Details and patient eligibility

About

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)

Enrollment: 200 estimated patients

Sex: All

Ages: 22+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Treatment Group

Treatment:

Device: NEVA VS