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Recruiting NCT06893588

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

— Observational Cerebral Vasospasm Aneurysmal Subarachnoid Hemorrhage (aSAH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NEVA VS.
Who it may be relevant to
Registry conditions: Cerebral Vasospasm, Aneurysmal Subarachnoid Hemorrhage (aSAH). Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prospective, Open-Label, Multi-Center ProceDural Data CollectIon Case Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (The DILATE Registry)

Overview

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

  • Device NEVA VS
    cerebral artery dilation device

Primary outcome measures

  • Improvement in target vessel diameter following NeVa VS use [Time frame: Up to 1 hour post procedure]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 16 centers
  • Providence St. Joseph Medical Center — Burbank
  • John Muir Health — Walnut Creek
  • Yale — New Haven
  • Baptist Health South Florida — Miami
  • Wellstar Health System — Marietta
  • Endeavor Health — Evanston
  • Univ Iowa — Iowa City
  • Univ Kentucky — Lexington
  • … and 8 more centers

Identifiers

NCT: NCT06893588 · VS-011

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗