About this trial
This is a prospective, multi-center, open-access, single-arm trial to observe the real-world clinical efficacy of drug-eluting vertebral artery stenting system treatment for Atherosclerotic Vertebral Arteries Stenosis. Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 1 year within 3 years.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years old, gender is not limited;
Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems;
Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form.
Disqualifiers
Unable to receive dual antiplatelet therapy due to known disease, or severe coagulation abnormalities, severe infections that are not controlled, severe systemic disease, uncontrollable hypertension, and contraindicated for surgery;
With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery;
Gastrointestinal disease with active bleeding;
Previous myocardial infarction or large-scale cerebral infarction within 2 weeks;
Trial design
Single group
Treatments tested in this trial
The drug-eluting stent
DeviceVertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials.
Treatment groups
Trial outcomes
Primary outcomes
Incidence of clinical ischemic events
Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion
Secondary outcomes
Clinical Success Rate
Successful arrival and release of the stent in the target lesion with complete coverage of the lesion and residual stenosis \<30%, no major adverse events (MAE).
Major adverse event (MAE) incidence
Major adverse events (MAE) include all-cause death, any type of stroke (ischemic/hemorrhagic stroke) within 30 days of surgery, TIA or ischemic stroke in the target lesion supply area within 1 year, clinically driven target lesion revascularization (CD-TVL), thrombotic event.
Incidence of bleeding events
Access or non access site bleeding
Incidence of in-stent restenosis
Restenosis: in-stent stenosis rate ≥50% on imaging
Sponsors and contacts
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