RecruitingNot ApplicableNCT05644314

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

Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

144 participants

Start Date

May 1, 2022

Study Type

INTERVENTIONAL

Conditions

Ischemic Stroke Vertebral Artery Stenosis

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

Min Age: 18 Years

Inclusion Criteria3

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.

Exclusion Criteria7

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;
Known contraindications to heparin, rapamycin, anesthesia, and contrast agents;
Life expectancy less than 12 months;
the investigator judged patients to be unsuitable for participation in this study.

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Interventions

DEVICEThe 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.