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

May 23, 2026 updated by: Vesalio

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

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Burbank, California, United States, 91505
      • Walnut Creek, California, United States, 94589
    • Connecticut
      • New Haven, Connecticut, United States, 06520
    • Florida
      • Miami, Florida, United States, 33143
        • Recruiting
        • Baptist Health South Florida
        • Contact:
    • Georgia
      • Marietta, Georgia, United States, 30062
    • Illinois
      • Evanston, Illinois, United States, 60201
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • Univ Iowa
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Recruiting
        • Univ Kentucky
        • Contact:
    • Maine
      • Portland, Maine, United States, 04102
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic- Rochester
        • Contact:
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15222
        • Recruiting
        • Allegheny Health Network
        • Contact:
      • Wilkes-Barre, Pennsylvania, United States, 18711
    • Texas
      • Harlingen, Texas, United States, 78550
        • Recruiting
        • Valley Baptist Medical Center- Harlingen
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas Health Science Center at Houston
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • West Virginia University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

subjects with cerebral vasospasm

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
Device: NEVA VS
cerebral artery dilation device

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vesalio

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2025

Primary Completion (Estimated)

February 14, 2027

Study Completion (Estimated)

March 15, 2027

Study Registration Dates

First Submitted

February 3, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 23, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VS-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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