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New balloon device aims to unclog brain arteries and prevent strokes

NCT ID NCT07170618

Disease control Sponsor: Sinomed Neurovita Technology Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026

Summary

This study tests a new balloon microcatheter in 56 people with severely narrowed brain arteries (70% or more blockage). The device can both widen the artery and deliver other treatments. Researchers will check if it works safely and effectively, tracking complications like strokes or vessel damage.

What this could mean

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

Active substance
balloon microcatheter
What this could lead to
If successful, this device could offer a safer, more effective way to open narrowed brain arteries and deliver treatments, potentially reducing stroke risk.
What could go wrong
This is an early-stage study with only 56 participants, so results may not apply to everyone. Risks include vessel damage, stroke, or device failure.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 56 people

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

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2025

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.

Ages

18 to 80 years

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. 18 to 80 years of age 2. Patients with intracranial artery stenosis (Degree of stenosis: ≥70%) 3. Target vessel reference diameter must be visually estimated to be 1.25 mm to 4.50 mm 4. Willingness to participate in this clinical trial and signing the consent form for patients or their legally authorised representatives Exclusion Criteria: 1. The proximal end of the target vessel is extremely tortuous, severely angulated, or heavily calcified, making it difficult for the device to reach the target vessel 2. Pre-existing severe respiratory, hepatic, or renal diseases (e.g., creatinine ≥ 3.0 mg/dL) or coagulation disorders 3. Disabling stroke with a baseline mRS score ≥ 3 points 4. Non-atherosclerosis diseases 5. Patients with stroke caused by branch occlusion 6. Patients who were participating in other clinical trials who had not yet reached the primary clinical endpoint 7. Known hypersensitivity to aspirin, heparin, anesthetics and contrast agents 8. Investigators consider the patient who is not suitable for enrolling in the present trial

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Conditions

The condition(s) this trial relates to.

cerebral artery stenosis

As listed by the trial registrant

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

Intracranial artery stenosis

How to take part

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

  1. The places running it

    1 site. 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

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.