Balloon treatment tested against drugs for stroke risk from narrowed brain arteries

NCT ID NCT07830277

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are comparing a drug-coated balloon procedure plus intensive medical care against intensive medical care alone in people with severely narrowed brain arteries that have caused stroke or mini-stroke symptoms. The trial enrolls 570 adults aged 18 to 80. Everyone receives aggressive medical management, including antiplatelet drugs and cholesterol-lowering therapy, while half also undergo the balloon procedure to widen the narrowed artery. The main goal is to see whether the balloon approach reduces the combined risk of stroke or death within the first month and stroke in the affected artery over the following year.

What this could mean

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

Active substance
a drug-coated balloon used to widen narrowed arteries in the brain
What this could lead to
If it works, this could offer a way to lower stroke risk for people whose brain arteries stay dangerously narrow despite intensive medical treatment.
What could go wrong
The procedure carries risks such as artery tears, clots, or bleeding, and it may not beat medical therapy alone. Results from this trial may not apply to everyone with narrowed brain arteries.

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 570 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Jun 2031

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. Age 18-80 years old, regardless of gender 2. Patients with symptomatic ICAS caused by stenosis of a major intracranial artery (the degree of ischemic stroke with target vessel stenosis within 90 days before enrollment is required to be 70-99%, or the degree of transient ischemic attack with target vessel stenosis is required to be 80-99%), standardized drug management of at least one antithrombotic drug and/or vascular risk factors 3. DSA or CTA confirmed that the stenosis degree of one main intracranial artery (internal carotid artery C4-C7 segment, middle cerebral artery M1 segment, vertebral artery V4 segment and basilar artery) was between 70% and 99% (measured by WASID method), and was corresponding to the clinical symptoms. The normal diameter of the proximal end of the target lesion was ≥ 2mm, and the length of the target lesion was ≤ 15mm 4. If the target lesion is located in the anterior circulation system (C4-C7 of the internal carotid artery or M1 of the middle cerebral artery), it is required that there is hypoperfusion in the blood supply area of the target vessel (at least one of the following conditions is met): ①head CTP or PWI showed that CBF in the target vessel area decreased significantly (the lesion side decreased by more than 30% compared with the opposite side); ②Cerebral infarction with hemodynamic abnormalities confirmed by head CT or MRI (such as watershed infarction); ③ASITN/SIR collateral circulation score based on DSA\<3 points) 5. Those who voluntarily participated in the study and signed the informed consent Exclusion Criteria: 1. Serious calcification of target vessels, or serious distortion of target vessels or anatomical factors make it difficult for interventional instruments to be in place 2. Severe stenosis or occlusion of extracranial or intracranial vessels in series at the proximal or distal end of the target vessel 3. Major surgical operations have been performed in recent 3 weeks 4. Cerebral hemorrhage, massive cerebral infarction (the infarct area is greater than 50% of the middle cerebral artery supply area; cerebellar infarction: the infarct diameter is greater than 3cm) and myocardial infarction have occurred in the past three months 5. The target lesion has undergone stent implantation before 6. Intracranial artery stenosis caused by non atherosclerotic lesions, including but not limited to: arterial dissection, moyamoya disease, vasculitis, radiation vascular disease or fibromuscular dysplasia 7. mRS score ≥ 3 8. Patients with coagulation dysfunction 9. Those who cannot tolerate anesthesia and anticoagulant drugs, are contraindicated or allergic to surgical drugs (paclitaxel, heparin, contrast agent, aspirin, clopidogrel, etc.), and are allergic to surgical instruments or operating devices 10. Platelet (PLT\<90×109/L),hematocrit (\<30%), international normalized ratio (INR)\>1.5, uncontrollable severe hypertension (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg),severe liver injury (ALT or AST more than 3 times the normal value), severe renal function injury (creatinine\>3mg/dl,\>265μmol/L),and severe insufficiency of other important organs such as heart and lung 11. The subjects participated in other clinical trials and have not completed the follow-up or the researchers judged that the patients' compliance was poor and they were unable to complete the follow-up as required 12. Pregnant or lactating women, or those who plan to become pregnant within one year 13. The disease will cause difficulties in treatment and follow-up evaluation (such as dementia or mental disorders, cancer, infection, severe metabolic diseases), and it is speculated that the life expectancy of the participants is less than 3 years 14. Other cases that clinicians think should be excluded

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 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

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014000, China

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100010, China

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