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)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06893588

Acronym

DILATE

Enrollment

200

Registered

2025-03-25

Start date

2025-04-14

Completion date

2027-03-15

Last updated

2026-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Subarachnoid Hemorrhage (aSAH), Cerebral Vasospasm

Keywords

vasospasm

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 subarachnoid hemorrhage (aSAH)

Interventions

DEVICENEVA VS

cerebral artery dilation device

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Improvement in target vessel diameter following NeVa VS use	Up to 1 hour post procedure

Countries

United States

Contacts

CONTACTSharon Shachar, Graduate

sshachar@vesalio.com2486976616

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 28, 2026