Drug‑coated stent treatment for symptomatic intracranial artery narrowing

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, randomized, non‑inferiority Phase 3 trial enrolling 224 patients across Chinese centers and stratifying randomization by anterior versus posterior circulation lesion location. Eligible adults with symptomatic intracranial atherosclerotic stenosis (TIA or ischemic stroke within 180 days) and 70–99% stenosis by DSA will be randomized via a centralized system to receive either the NxiDIME™ or NOVADES® intracranial drug‑eluting stent. The trial targets patients with poor collateral circulation or imaging evidence of hypoperfusion and lesions in vessels 1.0–5.5 mm in diameter. Clinical and imaging outcomes including stroke, restenosis, and device‑related complications will be tracked to compare safety and efficacy between the two devices.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Feng Gao, Ph.D
• Email: geofengletter@sina.com
• Phone: 13581936066

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.