Drug Eluting Stenting and Short Dual Antiplatelet Therapy for Preventing Recurrent Stroke in Vertebral Stenosis Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 520
- 试验地点
- 1
- 主要终点
- Occurrence of ischemic stroke in the territory of the target artery within 1 year
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 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.
排除标准
- •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.
研究组 & 干预措施
3 months DAPT
dual antiplatelet therapy (DAPT) for 3 months
干预措施: DAPT for 3 months after vertebral artery stenting (Drug)
结局指标
主要结局
Occurrence of ischemic stroke in the territory of the target artery within 1 year
时间窗: 12 months after stent implantation
The primary endpoint was defined as occurrence of ischemic stroke events in the target arterial territory, excluding transient ischemic attacks.
次要结局
- Occurrence of Periprocedural events(within 30 days after stent implantation)
- Occurrence of Bleeding Events within 1 year(12 months after stent implantation)
- Occurrence of TIA events related to the target territory within 1 year(12 months after stent implantation)
- Occurrence of disabling and fatal stroke events within 1 year(12 months after stent implantation)
- AEs and SAEs(in 12 months)
- Occurrence of residual stenosis after the procedure(At the end of the procedure)
- Rate of In-stent restenosis (ISR) within 12 months(12 months after stent implantation)
- modified Rankin Scale score at 1 year(12 months after stent implantation)
- The National Institutes of Health Stroke Scale (NIHSS) score at 1 year(12 months after stent implantation)
- EQ-5D score at 1 year(12 months after stent implantation)