The drug-eluting stent: Vertebral artery drug-eluting stents Maurora® was approved for marketing in 2020 and has been shown to be effective in reducing restenosis in clinical trials.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Age ≥ 18 years old, gender is not limited;
2. Patients with medically prescribed rapamycin drug-eluting vertebral artery stent systems;
3. Patients and family members fully understand the trial's purpose, voluntarily participate in the trial and sign the informed consent form.
Exclusion Criteria:
1. 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;
2. With an aneurysm that cannot be treated earlier or simultaneously or is not suitable for surgery;
3. Gastrointestinal disease with active bleeding;
4. Previous myocardial infarction or large-scale cerebral infarction within 2 weeks;
5. Known contraindications to heparin, rapamycin, anesthesia, and contrast agents;
6. Life expectancy less than 12 months;
7. the investigator judged patients to be unsuitable for participation in this study.
Primary outcome measure(s)
Incidence of clinical ischemic events — within 1 year Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion
Trial sites (1)
Facility
City
Region
Status
Nanfang Hospital of Southern Medical University
Guangzhou
Guangdong
Recruiting
More Nanfang Hospital, Southern Medical University trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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