Symptomatic intracranial atherosclerotic stenosis
Conditions
Interventions
Intervention group:Intracranial paclitaxel-coated balloon angioplasty (Taijieweiye, China)
Control group:Wingspan stenting (Stryker Neurovascular, USA)
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 18 to 80 years, male or female; 2. Stenotic vessels (70%-99% stenosis, diameter >= 2 mm, length <= 15 mm) in the internal carotid artery (intracranial segment), middle cerebral artery, basilar artery, vertebral artery (intracranial segment) or its branches; 3. Decreased blood perfusion in the blood supply area of the target vessel, hypoperfusion is needed to at least meet any of the following conditions: (1) Head CTP or PWI showed that CBF was significantly decreased in the diseased vascular area, with a 30% or more reduction in perfusion compared with the normal area; (2) ASITN/SIR collateral circulation score < 3 assessed by DSA; (3) Hemodynamic abnormal cerebral infarction (such as watershed infarct) confirmed by head MRI or CT; 4. Symptomatic intracranial arterial stenosis patients with recurrent or progressive stroke/transient ischemic attack (TIA) within the past 180 days; 5. Patients who failed to respond to best medical treatment (at least one antiplatelet agent or oral anticoagulant, receiving high-dose statins, lifestyle change and/or drug administration for risk factor control of secondary stroke) or those at high risk of stroke recurrence (with multiple risk factors, including previous or current hypertension, diabetes, hyperlipidemia, smoking) assessed by the investigator; 6. Subjects or their guardians are willing to comply with the requirements of the protocol and data collection procedures, understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Anatomic factors such as severe calcification or distortion of the target vessel make it difficult for the study device to reach the lesion site; 2. Severe stenosis or total occlusion of tandem extracranial or intracranial vessels found proximal or distal to the target vessel; 3. Acute ischemic stroke or major surgery in the past 3 weeks, or cerebral hemorrhage, massive cerebral infarction, cardiogenic stroke, myocardial infarction within the past 30 days; 4. A history of stenting for the target lesion; 5. Non-atherosclerotic stenosis caused by arterial dissection, Moyamoya disease, vasculitis, radiation angiopathy or fibromuscular dysplasia, etc; 6. Pre-enrollment modified Rankin Scale (mRS) score >= 3; 7. Coagulation dysfunction or irreversible bleeding; 8. Inability to tolerate general anesthesia, contraindication or severe allergy to procedure-related drugs (paclitaxel, heparin, contrast agent, aspirin or clopidogrel, etc.) or study devices; 9. Platelet count 1.5, severe hypertension refractory to medication (systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg), severe heart or lung failure, severe liver impairment (ALT or AST > 3 times the upper limit of normal) or kidney dysfunction (serum creatinine > 3 mg/dL); 10. Current participation in other studies applying drugs or devices; 11. Pregnancy or lactation in women, or pregnancy planning within 1 year; 12. The disease will cause difficulties in endovascular treatment and follow-up evaluation (such as dementia or mental disorders, cancer, infection, severe metabolic diseases), it is speculated that the life expectancy of participants is less than 3 years; 13. Other conditions rendering the patient unsuitable for enrollment per investigators’ judgement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis of target lesion; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;target lesion revascularizition;Any stroke (ischemic or hemorrhagic stroke) or all-cause death;modified Rankin Score (mRS);Major adverse cardiovascular and cerebrovascular events;Device defects;Symptomatic restenosis of target lesion;Recurrent ischemic events (stroke or TIA);Procedure-related complications (arterial dissection, arterial perforation, vasospasm requiring treatment, distal embolization, thrombus formation, etc.);All-cause death;Other serious adverse events; | — |
Countries
China
Contacts
Public ContactZhongrong Miao
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed