Symptomatic Vertebral Artery Ostium Stenosis
Conditions
Interventions
experimental group:Rapamycin drug-eluting stents combined with optimal medical therapy. Drug therapy consisted of dual antiplatelet therapy (aspirin 100mg once daily or cilostazol 100mg twice daily pl
control group:Bare metal stents combined with optimal medical therapy. Drug therapy consisted of dual antiplatelet therapy (aspirin 100mg once daily or cilostazol 100mg twice daily plus clopidogrel 75
Sponsors
the First Affiliated Hospital with Nanjing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years old; 2. The presence of posterior circulation ischemic symptoms such as vertigo, transient ischemic attack (TIA) or ischemic stroke related to the offending vessel within the past 6 months; 3. DSA confirmed severe stenosis (70-99%, NASCET) at the origin of the vertebral artery. Severe stenosis was found in the dominant vertebral artery or in both vertebral arteries with equal thickness; 4. The normal diameter of the vessel to be intervened is 2.5mm or more; 5. Presence of at least one risk factor for atherosclerosis, including hypertension, diabetes, hyperlipidemia, smoking history, or obesity; 6. Patients or their guardians provided written informed consent.
Exclusion criteria
Exclusion criteria: 1. Vertebral artery stenosis at the origin due to non-atherosclerotic lesions, including dissection, arteritis, radiation-induced stenosis, and fibromuscular dysplasia, should be considered; 2. Serial stenosis (50-99%) or occlusion of offending vessels; Basilar artery stenosis (50-99%) or occlusion, which may be related to symptoms; 3. The offending vessel has received previous surgery or stent implantation; 4. The patient had severe neurological dysfunction (mRS>3); 5. Other cerebrovascular diseases requiring simultaneous or short-term (1 year) surgery or interventional treatment; 6. Known severe allergy to iodinated contrast media or rapamycin; 7. Acute ischemic stroke within two weeks; 8. Parenchymal hemorrhage, subarachnoid hemorrhage, subdural hemorrhage, or epidural hemorrhage in the previous 3 months; 9. Significant abnormal coagulation function or bleeding tendency (such as INR>1.5 and/or platelet count <100×109/L); 10. There are other serious diseases (such as severe infection, severe chronic obstructive pulmonary disease, malignant tumor, dementia, mental illness, etc.) that affect the compliance of the program; 11. Pregnant or lactating women; 12. Other circumstances that may, in the judgment of the investigator, affect the evaluation of efficacy or safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Restenosis after stent placement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Any stroke or death occurred within 30 days of enrollment;Any stroke within 30 days of enrollment;silent cerebral infarction after operation;success rate of operation;Ischemic stroke in the territory of the responsible vessel was enrolled between 30 days and 1 year;Ischemic stroke in the territory of the responsible vessel occurred within 1 year of enrollment;Symptomatic restenosis occurred within 1 year of enrollment;Fatal or disabling stroke (mRS Score >= 3) occurred within 1 year of enrollment;Any stroke within 1 year of enrollment;TIA or ischemic stroke within 1 year of enrollment;Any stroke, myocardial infarction, or death within 1 year of enrollment;mRS Score at 1 year of enrollment;Death from any cause at 1 year;Success rates by different surgical approach, rates of postoperative silent cerebral infarction, rates of any stroke or death within 30 days, and rates of in-stent restenosis at 1 year; | — |
Countries
China
Contacts
Public ContactSheng Liu
the First Affiliated Hospital with Nanjing Medical University
Outcome results
None listed