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Balloon catheter may shield the brain from debris during artery stenting

NCT ID NCT07678164

Disease control Sponsor: Hebei General Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial tests whether using a balloon guide catheter along with a filter can better protect the brain during carotid artery stenting. People with narrowed neck arteries (carotid stenosis) who need stenting are randomly assigned to get either the balloon-plus-filter combo or a filter alone. The main goal is to see if the combo reduces new brain spots (infarcts) seen on MRI within two days after the procedure.

What this could mean

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

Active substance
Balloon guide catheter and distal embolic filter
What this could lead to
If it works, this approach could reduce the risk of stroke and brain injury during carotid artery stenting.
What could go wrong
This is a relatively small trial (132 people) testing a device procedure, so results may not apply to all patients. The procedure itself carries risks like stroke or heart attack.

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 132 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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. Aged between 18 and 80 years (inclusive), with no gender restriction. 2. Imaging diagnosis indicates symptomatic carotid artery stenosis (by NASCET method) ≥50% or asymptomatic carotid artery stenosis (by NASCET method) ≥70%. 3. Suitable for carotid artery stenting. 4. Good compliance, voluntarily signed the informed consent form, and able to follow up as required. Exclusion Criteria: 1. Severe tortuosity or calcification of the diseased vessel, preventing device delivery. 2. Patients with ipsilateral external carotid artery occlusion or severe stenosis of the intracranial segment of the internal carotid artery. 3. Patients with contralateral common carotid artery occlusion or severe stenosis or occlusion of the internal carotid artery. 4. Patients with severe stenosis or occlusion of the vertebrobasilar artery (excluding non-dominant vertebral artery). 5. Spontaneous intracranial hemorrhage, massive cerebral infarction, progressive stroke, or myocardial infarction within the past 3 months. 6. Presence of substantial acute or subacute thrombus adjacent to the lesion. 7. mRS \> 3. 8. Patients with a clear risk of cardioembolism, such as atrial fibrillation, or those with definite indications for anticoagulation. 9. Chronic obstructive pulmonary disease requiring long-term continuous oxygen therapy. 10. Patients with prior stent treatment in the ipsilateral head and neck vessels. 11. Patients with end-stage renal failure requiring dialysis. 12. Life expectancy less than 6 months. 13. Patients unsuitable for magnetic resonance imaging (MRI) for any reason. 14. Patients with absolute or relative contraindications to antiplatelet therapy. 15. Inability to cooperate with the study due to dementia or mental disorder.

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Conditions

The condition(s) this trial relates to.

carotid stenosis

As listed by the trial registrant

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

Carotid artery stenosis

How to take part

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  1. 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 ↗

  2. A doctor treating you

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