Drug‑coated stent treatment for symptomatic intracranial artery narrowing

A Prospective, Multi-center, Randomized Controlled, Clinical Trial to Evaluate the Safety and Efficacy of NxiDIME™ Intracranial Drug-eluting Self-expanding Stent System

This trial will test whether the NxiDIME drug‑coated intracranial stent is at least as safe and effective as the NOVADES drug‑coated stent in adults (18–80) with symptomatic severe intracranial artery narrowing.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07197970 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–80 who had a TIA or ischemic stroke in the target intracranial artery within 180 days, have 70–99% stenosis by DSA, poor collaterals or hemodynamic hypoperfusion, target vessel diameter 1.0–5.5 mm, and are on antiplatelet therapy are the intended candidates.

Not a fit: People without recent ischemic symptoms, with stenosis under 70% (or outside the 70–99% range), with adequate collateral circulation or no hypoperfusion, with target vessels outside 1.0–5.5 mm, or with contraindications to stenting or antiplatelet drugs are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this could provide an additional drug‑eluting stent option that lowers restenosis and recurrent stroke risk for people with severe symptomatic intracranial stenosis.

How similar studies have performed: Earlier randomized trials of intracranial stenting (for example SAMMPRIS) raised safety concerns with older devices, while smaller nonrandomized series of intracranial drug‑eluting stents have reported lower restenosis rates, but robust randomized phase‑3 evidence for DES is still limited.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• 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

Conditions Symptomatic Intracranial Atherosclerotic Stenosis; symptomatic intracranial atherosclerotic stenosis; Drug-Eluting Stent; strok