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New brain artery device under Real-World watch

NCT ID NCT06893588

Disease control Sponsor: Vesalio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is tracking how well a device called NeVa VS works to open narrowed brain arteries in people who had a bleeding aneurysm. The device is already approved for this use, and researchers want to see how it performs in routine care. About 200 adults will be followed to measure artery widening and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NeVa VS cerebral artery dilation device
What this could lead to
If successful, this registry could confirm that the NeVa VS device safely widens narrowed brain arteries after aneurysm bleeding, offering a reliable treatment option.
What could go wrong
This is an observational registry, not a controlled trial, so it cannot prove the device works better than alternatives. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

subjects with cerebral vasospasm

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

acquired aneurysmal subarachnoid hemorrhage intracranial vasospasm subarachnoid hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aneurysmal subarachnoid hemorrhage (ASAH) Cerebral vasospasm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny Health Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15222, United States

  • Baptist Health South Florida

    RECRUITING

    Miami, Florida, 33143, United States

  • Endeavor Health

    RECRUITING

    Evanston, Illinois, 60201, United States

  • Geisinger

    RECRUITING

    Wilkes-Barre, Pennsylvania, 18711, United States

  • John Muir Health

    RECRUITING

    Walnut Creek, California, 94589, United States

  • MaineHealth

    RECRUITING

    Portland, Maine, 04102, United States

  • Mayo Clinic- Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Providence St. Joseph Medical Center

    RECRUITING

    Burbank, California, 91505, United States

  • Uni. of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Univ Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • Univ Kentucky

    RECRUITING

    Lexington, Kentucky, 40506, United States

  • University of Texas Health Science Center at Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • Valley Baptist Medical Center- Harlingen

    RECRUITING

    Harlingen, Texas, 78550, United States

  • Wellstar Health System

    RECRUITING

    Marietta, Georgia, 30062, United States

  • West Virginia University

    RECRUITING

    Morgantown, West Virginia, 26505, United States

  • Yale

    RECRUITING

    New Haven, Connecticut, 06520, United States

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