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

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)

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Key information

Conditions

Cerebral Vasospasm Aneurysmal Subarachnoid Hemorrhage (aSAH) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases Vasospasm, Intracranial

Age range

22 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Providence St. Joseph Medical Center, Burbank, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NeVa VS

Device

cerebral artery dilation device

Primary outcomes

Improvement in target vessel diameter following NeVa VS use

Time frame: Up to 1 hour post procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Sharon Shachar, Graduate

CONTACT

[email protected]

2486976616

Sponsors and collaborators

Lead sponsor

Vesalio

Industry

Registry information

Official study 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)

Acronym: DILATE

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: Mar 25, 2025
Registry last updated: May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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