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RECRUITINGINTERVENTIONAL

Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis

Efficacy of Drug-Eluting Vertebral Artery Stenting Treatment for Atherosclerotic Vertebral Arteries Stenosis in Real-World Clinical Observations: a Prospective, Multicenter, Open-access, Single-arm Clinical Study

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DEVICE

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.

Locations (1)

Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China