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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Incidence of clinical ischemic events
研究概览
简要总结
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.
详细描述
Stroke has been one of the most important causes of disability and death worldwide today. Ischemic stroke accounts for more than 50% of these strokes. The results of epidemiological surveys show that in 2018, more than 3 million new strokes occurred each year in China. In 2018, more than 3 million people suffered from a stroke, and more than 2 million people died from a stroke. Studies show that about 25% to 40% of transient ischemic attacks (TIA) or strokes occur in the posterior circulation. The subclavian and vertebral arteries are important blood vessels in the posterior circulation and are important original sites for ischemic strokes in the posterior circulation. About 20% of strokes in the posterior circulation are caused by extracranial vertebral artery stenosis (ECVAS). Endovascular intervention is the recommended treatment for ECVAS. It is effective in promoting the perfusion of brain tissue in the area of the responsible artery, thereby reducing the risk of stroke recurrence, improving neurological prognosis, and reducing symptoms. The drug-eluting stent is effective in reducing the incidence of postoperative restenosis (ISR), thus further reducing the long-term risk of stroke. 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. The purpose of this study is to further investigate its long-term effectiveness in treating vertebral artery stenosis in the real world.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Incidence of clinical ischemic events
时间窗: within 1 year
Examples of clinical cerebral ischemic events: TIA or ischemic stroke event in the blood supply area of the target lesion
次要结局
- Change in NIHSS scores(1 month, 6 months, 12 months, 2 and 3 years)
- Correlation of risk factors with the occurrence of major adverse events(1 month, 6 months, 12 months, 2 and 3 years)
- Evaluation of clinical use for relative contraindications(1 month, 6 months, 12 months, 2 and 3 years)
- Incidence of bleeding events(30 days and 1 year)
- Incidence of in-stent restenosis(within 1 year)
- Changes in the modified Rankin scale (mRS) scores(1 month, 6 months, 12 months, 2 and 3 years)
- Correlation of risk factors with the occurrence of restenosis(1 month, 6 months, 12 months, 2 and 3 years)
- Major adverse event (MAE) incidence(1 month, 6 months, 12 months, 2 and 3 years)
- Clinical Success Rate(within 1 year after surgery)
研究者
jizhong
Associate chief physician
Nanfang Hospital, Southern Medical University