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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Incidence of clinical ischemic events [Срок оценки: within 1 year]

Вторичные конечные точки (9)

• Clinical Success Rate [Срок оценки: within 1 year after surgery]
• Major adverse event (MAE) incidence [Срок оценки: 1 month, 6 months, 12 months, 2 and 3 years]
• Incidence of bleeding events [Срок оценки: 30 days and 1 year]
• Incidence of in-stent restenosis [Срок оценки: within 1 year]
• Changes in the modified Rankin scale (mRS) scores [Срок оценки: 1 month, 6 months, 12 months, 2 and 3 years]
• Change in NIHSS scores [Срок оценки: 1 month, 6 months, 12 months, 2 and 3 years]
• Correlation of risk factors with the occurrence of major adverse events [Срок оценки: 1 month, 6 months, 12 months, 2 and 3 years]
• Correlation of risk factors with the occurrence of restenosis [Срок оценки: 1 month, 6 months, 12 months, 2 and 3 years]
• Evaluation of clinical use for relative contraindications [Срок оценки: 1 month, 6 months, 12 months, 2 and 3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Nanfang Hospital of Southern Medical University — Гуанчжоу

Публикации

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• Marquardt L, Kuker W, Chandratheva A, Geraghty O, Rothwell PM. Incidence and prognosis of > or = 50% symptomatic vertebral or basilar artery stenosis: prospective population-based study. Brain. 2009 Apr;132(Pt 4):982-8. doi: 10.1093/brain/awp026. Epub 2009 Mar 17. PMID 19293244
• Caplan LR, Amarenco P, Rosengart A, Lafranchise EF, Teal PA, Belkin M, DeWitt LD, Pessin MS. Embolism from vertebral artery origin occlusive disease. Neurology. 1992 Aug;42(8):1505-12. doi: 10.1212/wnl.42.8.1505. PMID 1641144
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• Markus HS, Harshfield EL, Compter A, Kuker W, Kappelle LJ, Clifton A, van der Worp HB, Rothwell P, Algra A; Vertebral Stenosis Trialists' Collaboration. Stenting for symptomatic vertebral artery stenosis: a preplanned pooled individual patient data analysis. Lancet Neurol. 2019 Jul;18(7):666-673. doi: 10.1016/S1474-4422(19)30149-8. Epub 2019 May 23. PMID 31130429

Идентификаторы

NCT: NCT05644314 · NFEC-2022-410

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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