New brain stent aims to keep arteries open and prevent strokes
NCT ID NCT07197970
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 224 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2025
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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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
RECRUITINGBeijing, Beijing Municipality, 100000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Balloon treatment tested against drugs for stroke risk from narrowed brain arteries
- New balloon coated with paclitaxel aims to keep brain arteries open
- Balloon breakthrough: could a Drug-Coated device prevent stroke?
- Cholesterol control may cut stroke risk in brain artery disease
- New combo therapy shows promise in preventing stroke worsening
- New stent aims to prevent stroke in patients with clogged brain arteries