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New stent aims to prevent stroke in patients with clogged brain arteries

NCT ID NCT07352852

Disease control Sponsor: The Affiliated Hospital of Qingdao University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 testing a special stent coated with the drug rapamycin to treat narrowed brain arteries in people who haven't gotten better with medication alone. About 300 participants will receive the stent and be monitored for up to a year to see if it reduces the risk of stroke or death. The trial also checks for re-narrowing of the artery and overall safety.

What this could mean

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

Active substance
rapamycin-eluting stent
What this could lead to
If successful, this could provide a better treatment option for people with narrowed brain arteries who haven't improved with medication, potentially reducing their risk of stroke.
What could go wrong
This is a single-arm study without a comparison group, so results may be less definitive. The stent procedure itself carries risks like stroke or death, and long-term benefits beyond 1 year are not yet known.

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 300 people

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

Started

May 2025

Expected to finish

Dec 2028

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.

Who is studied

subjects undergoing rapamycin-eluting stent implantation

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: * Age ≥18 and ≤80 years; * Symptomatic intracranial atherosclerotic stenosis patients with ineffective medical treatment; * Digital subtraction angiography (DSA) shows target lesion stenosis ≥70%; * Suitable for implantation of rapamycin-targeted drug-eluting stents; * The patient and/or their authorized representative can understand the study purpose, agree to participate, and sign the informed consent form. Exclusion Criteria: * Modified Rankin Scale (mRS) score ≥3; * Ischemic stroke within the past 2 weeks; * Presence of more than 2 intracranial atherosclerotic stenosis lesions requiring interventional treatment; * Severe contraindications to heparin, aspirin, ticagrelor, clopidogrel, or other antiplatelet drugs, and inability to tolerate anticoagulant/antiplatelet therapy; * Severe dysfunction of major organs (e.g., severe hepatic insufficiency, renal insufficiency, heart failure); * Severe allergies to contrast agents, rapamycin and its derivatives, cobalt-based alloys, or polylactic acid; * Pregnant or lactating women; * Participation in other drug or device studies without reaching the endpoint; * Life expectancy less than 12 months; * Lesions or vascular access deemed unsuitable for rapamycin drug-eluting stent implantation by the operator.

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Conditions

The condition(s) this trial relates to.

brain disorder cerebral artery stenosis intracranial arterial disease

As listed by the trial registrant

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

Brain diseases Intracranial arterial 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

  • Qingdao University Affiliated Hospital

    RECRUITING

    Qingdao, Shandong, China

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