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Brain artery stent coated with drug may cut stroke risk better than pills alone

NCT ID NCT04948749

Disease control Sponsor: Beijing Tiantan Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time

Summary

This trial compares two strategies to prevent another stroke in people with severe narrowing of a major brain artery. One group receives a drug-eluting stent (a mesh tube that releases medication to keep the artery open) along with aggressive blood-thinning medication. The other group gets medication alone. The study tracks who has a stroke, dies, or experiences serious bleeding within one 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-eluting stent (Maurora Sirolimus-Eluting Stent) plus aggressive medical treatment (dual antiplatelet therapy with aspirin and clopidogrel)
What this could lead to
If successful, this approach could offer a more effective way to prevent repeat strokes in people with hardened brain arteries, potentially reducing disability and death.
What could go wrong
This is a mid-sized trial, and stenting carries risks like bleeding or vessel damage. The results may not apply to all patients or artery locations.

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 358 people

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

Started

Jul 2021

Expected to finish

Dec 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 85 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 from 18 to 85 years 2. Patients with ischemic stroke within 30 days of enrolment attributed to 70% to 99% stenosis of a major intracranial artery (internal carotid artery \[C5-C7\], middle cerebral artery \[M1\], vertebral artery \[V4\], or basilar artery) on CTA (According to WASID method) 3. The diameter of the target vessel between 2.0mm - 4.5mm 4. The stenosis lesion length ≤ 14 mm 5. Baseline modified Rankin Scale (mRS) score ≤ 3 6. Patient understands the purpose and requirements of the study, and has provided informed consent Exclusion Criteria: 1. Ischemic stroke occurred within 7 days before enrolment 2. Tandem extracranial or intracranial stenosis (70%-99%) or occlusion that is proximal or distal to the target intracranial lesion (NOTE: an exception is allowed if stenosis or occlusion involves a single vertebral artery proximal to a symptomatic basilar artery stenosis and the contralateral vertebral artery is supplying the basilar artery) 3. Bilateral intracranial vertebral artery stenosis of 70%-99% and uncertainty about which artery is symptomatic (NOTE: an exception is that if bilateral vertebral arteries with 70%-99% stenosis but unequal in size, the dominant side is considered as symptomatic) 4. Unilateral vertebral artery stenosis of 70%-99% with normal contralateral vertebral artery 5. Stroke caused by perforating artery occlusion 6. CT angiographic evidence of severe calcification at target lesion 7. Any history of brain parenchymal or subarachnoid, subdural or extradural haemorrhage in the past 6 weeks 8. Intracranial artery stenosis caused by non-atherosclerotic lesions, including: arterial dissection, Moyamoya disease, vasculitis disease, herpes zoster, varicella-zoster or other viral vascular diseases, neurosyphilis, any other intracranial infections, any intracranial stenosis related to cerebrospinal fluid cells, radiation-induced vascular disease, fibromuscular dysplasia, sickle cell disease, neurofibromatosis, central nervous system benign vascular disease, postpartum vascular disease, suspected vasospasm, suspicious embolism recanalization, etc 9. History of stenting of an intracranial artery 10. Presence of any unequivocal cardiac source of embolism 11. Combined with intracranial tumor, aneurysm or intracranial arteriovenous malformation 12. Cannot tolerate dual antiplatelet therapy 13. Contraindications to heparin, rapamycin, contrast and local or general anesthesia 14. Hemoglobin\<100g/L, platelet count \<100×109/L 15. Severe hepatic and renal dysfunction 16. INR\>1.5 or there are uncorrectable factors leading to bleeding 17. Major surgery within the past 30 days or planned within 90 days 18. Renal artery, iliac artery, and coronary artery requiring simultaneous intervention 19. Life expectancy \<1 year 20. Pregnant or lactating women 21. Cannot complete the follow-up due to cognitive, emotional or mental illness 22. Other situations that are not suitable for enrolment according to the judgement of the investigator 23. Enrolment in another study that would conflict with the current study

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Conditions

The condition(s) this trial relates to.

cerebral atherosclerosis intracranial arterial disease intracranial arteriosclerosis stroke disorder prevention target

As listed by the trial registrant

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

Drug eluting stents (DES) Drug-eluting stent Icad - intracranial atherosclerotic disease Icas - intracranial atherosclerosis Medical treatment Stroke

How to take part

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

  1. The places running it

    18 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

    RECRUITING

    Baotou, Inner Mongolia, China

  • Beijing Daxing District People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, China

  • Beijing Tiantan Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100070, China

  • Beilun People's Hospital of Ningbo City

    RECRUITING

    Ningbo, Zhejiang, China

  • General Hospital of Benxi Iron and Steel Co

    RECRUITING

    Benxi, Liaoning, China

  • General Hospital of The Yangtze River Shipping

    RECRUITING

    Wuhan, Hubei, China

  • Hejian People's Hospital

    RECRUITING

    Cangzhou, Hebei, China

  • Inner Mongolia Autonomous Region People's Hospital

    RECRUITING

    Hohhot, Inner Mongolia, China

  • Lishui People's Hospital

    RECRUITING

    Lishui, Zhejiang, China

  • North China University of Science and Technology Affiliated Hospital

    RECRUITING

    Tangshan, Hebei, China

  • Shanxi Cardiovascular Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • Shanxi Provincial People's Hospital

    RECRUITING

    Taiyuan, Shanxi, China

  • The First Affiliated Hospital of College of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

  • The Second Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, Jiangsu, China

  • The Second Norman Bethune Hospital of JilinUniversity,

    RECRUITING

    Changchun, Jilin, China

  • Tongliao City Hospital

    RECRUITING

    Tongliao, Inner Mongolia, China

  • Wuhai People's Hospital

    RECRUITING

    Wuhai, Inner Mongolia, China

  • Xingtai City Third Hospital

    RECRUITING

    Xingtai, Hebei, China

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