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New brain stent aims to keep arteries open and prevent strokes

NCT ID NCT07197970

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug-coated stent (NxiDIME) for people with severely narrowed brain arteries that have already caused a mini-stroke or stroke. The goal is to see if it keeps the artery open better than an existing stent. About 224 adults will be randomly assigned to get either the new or the standard stent and will be followed for a year.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 224 people

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

Started

May 2025

Expected to finish

May 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. Age ≥ 18 years old and ≤ 80 years old, regardless of gender. 2. Symptomatic intracranial arterial stenosis (TIA/ischemic stroke within 180 days attributed to intracranial arteries including the intracranial internal carotid artery, middle cerebral artery, intracranial vertebral artery, or basilar artery, with stenosis severity ≥70% and ≤99% measured by DSA using WASID criteria), currently receiving at least one antiplatelet therapy; 3. Poor collateral circulation or hypoperfusion in the target vessel territory (Poor collateral circulation: American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) score \< 3; Hypoperfusion: 1. The cerebral blood flow (CBF) in the target artery territory decreases by \> 30% during CT or magnetic resonance perfusion imaging (MR perfusion); or 2. There are hemodynamic ischemic lesions on MRI or CT, such as watershed infarction); 4. Target lesion vessel diameter 1.0-5.5 mm with lesion length ≤40 mm (If: 2.25 mm ≤ target vessel diameter ≤4.0 mm and lesion length ≤15 mm, enroll in randomized controlled study; 1.0 mm ≤ target vessel diameter \<2.25 mm or 4.0 mm \< target vessel diameter ≤5.5 mm or 15 mm \< lesion length ≤40 mm, enroll in single-arm cohort study); 5. mRS score ≤ 2; 6. Patient or legal guardian voluntarily participates and signs the written ICF, with willingness to comply with protocol-specified examinations and follow-up. Exclusion Criteria: 1. History of prior stent implantation or surgical treatment at the target lesion; 2. Intracranial hemorrhage within 30 days preoperatively or presence of untreated chronic subdural hematoma ≥5 mm; 3. Major surgical procedure within 30 days prior to the procedure; 4. Acute ischemic stroke within 14 days prior to the procedure; 5. Symptomatic carotid stenosis ≥50% outside the target lesion, or coexisting intracranial/extracranial vascular stenosis ≥70% requiring intervention; 6. Severe calcification, significant stenosis, or tortuosity of the target vessel precluding device deployment as assessed by investigators; 7. Intracranial tumor, arteriovenous malformation, or tandem aneurysms proximal/distal to the target lesion; 8. Non-atherosclerotic stenosis etiology (e.g., arterial dissection, moyamoya disease, vasculitis); 9. Cardiac thromboembolic sources (e.g., atrial fibrillation, left ventricular thrombus, myocardial infarction within 6 weeks); 10. Uncontrolled hypertension (persistent systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg); 11. Contraindications to antiplatelet/anticoagulant therapy, coagulopathy or bleeding diathesis precluding intervention per investigator judgment; 12. Severe comorbidities: cardiac failure (New York Heart Association (NYHA) Class III-IV), respiratory/renal failure (serum creatinine \>3.0 mg/dL (264 μmol/L)), Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) more than 3 times the upper limit of the normal value), active malignancy; 13. Hypersensitivity to rapamycin, polylactic-co-glycolic acid, nitinol, platinum-tungsten, anesthetics, or contrast agents; 14. Life expectancy \<1 year; 15. Pregnancy, lactation, or planned pregnancy within 1 year; 16. Concurrent participation in other clinical trials without completing primary endpoint follow-up; 17. Cognitive impairment or psychiatric disorders compromising protocol compliance; other exclusionary conditions per investigator discretion.

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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

    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

  • A prospective, multi-center, randomized controlled, non-inferiority clinical trial to evaluate the safety and efficacy of the NxiDIME™ Intracranial Drug-Eluting Stent System in the treatment of symptomatic intracranial atherosclerotic stenosis lesions

    RECRUITING

    Beijing, Beijing Municipality, 100000, China

More trials for these conditions

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