Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study

Обзор

This is a prospective, multi-center, registry study exploring the duration of dual antiplatelet therapy (DAPT) after drug-eluting stent(DES) treatment of symptomatic vertebral artery atherosclerotic stenosis. The trial will be conducted in approximately 30 interventional neurology centers in China. Currently, there is no consensus regarding the duration of DAPT after drug-eluting stent treatment for vertebral artery stenosis(VAS). The objective of this study is to standardize clinical medication by shortening the duration of DAPT, thereby reducing the bleeding risk and medication burden for patients, while ensuring that there is no increase in ischemic events.

Подробное описание

As the drug-eluting stents (DES) with indications for vertebral artery treatment have been officially approved in China, DES has gradually been widely used in the treatment of vertebral artery stenosis. There is increasing clinical attention towards the duration of dual antiplatelet therapy (DAPT) following stenting.

Currently, there is limited evidence regarding the optimal DAPT duration following endovascular treatment for vertebral artery stenosis. Therefore, clinical practice typically relies on experiences derived from treatments for coronary, carotid, or lower limb artery diseases, with a conventional recommendation of 6 to 12 months of antiplatelet therapy post-stent implantation.

Evidence obtained from coronary stents shows that the short-term DAPT strategy of 1-3 months after PCI in the new generation of DES can significantly reduce the incidence of severe bleeding without increasing ischemic events compared with the standard DAPT strategy of 7-12 months, especially for non-acute elective surgery patients who are similar to those with vertebral artery stenosis stents.

This study employs new-generation Co-Cr fluoropolymer DES to evaluate the balance between ischemic and bleeding complications by shortening the DAPT duration, with the ultimate aim of maximizing patient benefits.

Вмешательства

• Препарат DAPT for 3 months after vertebral artery stenting
  After implantation of a drug-eluting stent in the vertebral artery, dual antiplatelet therapy (DAPT) were administered for 3 months. The types of antiplatelet medications are not limited, with the standard regimen consisting of aspirin 100 mg once daily combined with either clopidogrel 75 mg once daily or ticagrelor 90 mg twice daily. Additional antiplatelet agents such as indobufen may also be considered acceptable.

Первичные конечные точки

• Occurrence of ischemic stroke in the territory of the target artery within 1 year [Срок оценки: 12 months after stent implantation]

Вторичные конечные точки (10)

• Occurrence of Periprocedural events [Срок оценки: within 30 days after stent implantation]
• Occurrence of Bleeding Events within 1 year [Срок оценки: 12 months after stent implantation]
• Occurrence of TIA events related to the target territory within 1 year [Срок оценки: 12 months after stent implantation]
• Occurrence of disabling and fatal stroke events within 1 year [Срок оценки: 12 months after stent implantation]
• AEs and SAEs [Срок оценки: in 12 months]
• Occurrence of residual stenosis after the procedure [Срок оценки: At the end of the procedure]
• Rate of In-stent restenosis (ISR) within 12 months [Срок оценки: 12 months after stent implantation]
• modified Rankin Scale score at 1 year [Срок оценки: 12 months after stent implantation]
• The National Institutes of Health Stroke Scale (NIHSS) score at 1 year [Срок оценки: 12 months after stent implantation]
• EQ-5D score at 1 year [Срок оценки: 12 months after stent implantation]

Критерии участия

Критерии включения

• Age ≥18 years old, gender unlimited;
• Based on clinical and imaging evidence, the investigators identified patients with symptomatic vertebral atherosclerotic stenosis who met the indications for the placement of drug-eluting vertebral artery stents;
• Patients or their guardians sign informed consent.

Критерии исключения

• Severe coagulation dysfunction, serious uncontrolled infection, serious systemic disease, uncontrolled hypertension, etc., are not suitable for surgery;
• Patients with aneurysms that cannot be treated in advance or at the same time or are not suitable for surgery;
• Myocardial infarction or large-scale cerebral infarction occurred within 2 weeks;
• Combined with atrial fibrillation, or accompanied by serious heart, liver, kidney and lung diseases;
• Interventional or surgical procedures are planned within 90 days;
• Known contraindications to heparin, rapamycin, anesthesia and contrast agents;
• Life expectancy is less than 12 months;
• The researcher considers it inappropriate to participate in this study.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT06683300 · KY2024-158-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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